Pfizer

Amnesty says COVID jab producers are causing human rights crisis

Amnesty International has slammed the six pharma companies behind the bulk of COVID-19 vaccine supplies of for not agreeing to waive their intellectual property rights and share the technology behind them. The charity says AstraZeneca, BioNTech, Johnson & Johnson, Moderna, Novavax, and Pfizer are fuelling an “unprecedented human rights crisis” as a result and their …

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Big pharma fuelling human rights crisis over Covid vaccine inequity – Amnesty

Six companies warned not to put profit before lives as report shows less than 1% of almost 6bn doses have gone to low-income countries Amnesty International has accused six pharmaceutical companies that have developed Covid-19 vaccines of fuelling a global human rights crisis, citing their refusal to sufficiently waive intellectual property rights, share vaccine technology …

Big pharma fuelling human rights crisis over Covid vaccine inequity – Amnesty Read More »

Pfizer, BioNTech prep low-dose COVID jab filing for kids aged 5 to 11

With positive phase 2/3 results for their COVID-19 vaccine Comirnaty in hand for the five to 11 age group, Pfizer and BioNTech are planning to move swiftly ahead with a filing for emergency use that could be approved in a matter of weeks. The data is the first generated with any COVID-19 vaccine in this …

Pfizer, BioNTech prep low-dose COVID jab filing for kids aged 5 to 11 Read More »

Pfizer, BioNTech prep low-dose COVID jab filing for kids aged 5 to 11

With positive phase 2/3 results for their COVID-19 vaccine Comirnaty in hand for the five to 11 age group, Pfizer and BioNTech are planning to move swiftly ahead with a filing for emergency use that could be approved in a matter of weeks. The data is the first generated with any COVID-19 vaccine in this …

Pfizer, BioNTech prep low-dose COVID jab filing for kids aged 5 to 11 Read More »

Pfizer reports positive Covid-19 vaccine data in kids; FDA is filing coming

A lower-dose version of Pfizer and BioNTech’s Covid-19 vaccine showed safety and efficacy results in children 5 to 11 that were comparable to those in an older age group. With these preliminary data, the companies said they plan to seek emergency use authorization of the shots.

EU panel rejects Pfizer’s tanezumab for osteoarthritis pain

Any lingering hope that Pfizer’s may finally get a regulatory approval for its nerve growth factor (NGF) inhibitor tanezumab looks to have been dashed after the EMA’s human medicines committee rejected the drug. A positive recommendation was already looking like a long shot for after FDA advisors voted 15 to one against approval of the …

EU panel rejects Pfizer’s tanezumab for osteoarthritis pain Read More »

FDA panel backs booster shots in high-risk groups after rejecting broader proposal

An FDA advisory panel voted down a proposal for booster shots of the Pfizer/BioNTech Covid-19 in the general population, opting instead to support third shots in certain high-risk groups, such as the elderly. Panelists want to see more information supporting the need for a booster, as well as data about a heart safety risk the …

FDA panel backs booster shots in high-risk groups after rejecting broader proposal Read More »

Ahead of FDA adcomm, Pfizer, Moderna say COVID jab efficacy dips

Pfizer and Moderna have both reported data that they say backs up the need for booster shots of their COVID-19 vaccines ahead of an FDA advisory committee meeting tomorrow, although the regulator seems less convinced. Documents published ahead of the panel by the FDA reviewers suggest that there is some evidence from observational studies that …

Ahead of FDA adcomm, Pfizer, Moderna say COVID jab efficacy dips Read More »

EFPIA: Partnership is the key to healthcare’s biggest challenges

The European pharma body’s new Health Collaboration Guide hopes to inspire greater partnership working across healthcare, showcasing award-winning collaborations involving Pfizer, Janssen, Novartis and more. Partnership is the key to unlocking the solutions to our major healthcare challenges, and “no player has a monopoly on good ideas”. That’s according to the European Federation of Pharmaceutical …

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ObsEva files uterine fibroid drug in US, chasing AbbVie, Myovant

Swiss biopharma company ObsEva has filed its oral GnRH antagonist linzagolix for the treatment of uterine fibroids in the US, hoping to expand the number of women eligible for this type of therapy. If approved, linzagolix will be the only drug in the class with a dosing regimen intended for women with uterine fibroids who …

ObsEva files uterine fibroid drug in US, chasing AbbVie, Myovant Read More »

UK poised to announce booster COVID jabs for over-50s

The UK government is due to announce a large-scale booster vaccine campaign against COVID-19 for all adults aged 50 and over later today, adding to its plan for third doses for people with weakened immune systems. The plan will see millions of doses of the Pfizer/BioNTech mRNA vaccine administered across the autumn and winter to …

UK poised to announce booster COVID jabs for over-50s Read More »

FDA sets expectations for pediatric Covid-19 vaccines; decision could come mid-fall

Acknowledging the demand for a Covid-19 vaccine for children, the FDA said it expects regulatory review could take weeks, not months, depending on the timing of a submission from vaccine developers. U.S. health officials told Reuters they expect the Pfizer/BioNTech vaccine will be the first one ready for an FDA submission.

BioNTech to seek approval for Covid jabs for younger children

Company behind Pfizer vaccine expected to file results of trial of five- to 11-year-olds with regulator soon Coronavirus – latest updates See all our coronavirus coverage The German company BioNTech, which developed the Pfizer vaccine, expects to seek approval from regulators for Covid jabs suited for younger children as early as mid-October, its founders have …

BioNTech to seek approval for Covid jabs for younger children Read More »

MHRA clears third doses of AZ, Pfizer COVID jabs

The UK medicines regulator has cleared the use of a third dose of both the AstraZeneca and Pfizer COVID-19 vaccines, in readiness for a possible booster campaign ahead of the winter months. The decision means there is now no impediment to starting a booster drive – assuming the Joint Committee on Vaccination and Immunisation (JCVI) …

MHRA clears third doses of AZ, Pfizer COVID jabs Read More »

Pfizer accused of holding Brazil ‘to ransom’ over vaccine contract demands

Leaked supply document reveals clauses to protect US pharma company from legal action in the event of serious side-effects Coronavirus – latest updates See all our coronavirus coverage Pfizer has been accused of holding Brazil “to ransom” over demands to shield itself from possible vaccine side-effect lawsuits in its contract to supply the country with …

Pfizer accused of holding Brazil ‘to ransom’ over vaccine contract demands Read More »

Pfizer gets first approval, in UK, for Xeljanz follow-up Cibinqo

Pfizer has claimed its first regulatory approval worldwide for Cibinqo, its JAK inhibitor for atopic dermatitis, from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The green light covers England, Scotland Wales, as Northern Ireland remains under the EU regulatory framework, and covers once-daily use of the orally-active drug in adolescents aged over 12 …

Pfizer gets first approval, in UK, for Xeljanz follow-up Cibinqo Read More »

Pfizer’s RSV Vaccine; Forte Biosciences’ Atopic Dermatitis Asset; Bone Therapeutics’ Osteoarthritis Programme; JandJ’s HIV Vaccine Trial; Versanis Bio $70 M Series A Financing; AC Immune’s Alzheimer’s Antibody Drug

Pfizer’s RSV Vaccine enters in the late-stage of clinical trials  As the battle to get an effective Respiratory Syncytial Virus (RSV) vaccine on the market heats up, Pfizer is launching a critical late-stage study of its experimental vaccine against a severe version of a cold virus that may cause pneumonia and death in the young …

Pfizer’s RSV Vaccine; Forte Biosciences’ Atopic Dermatitis Asset; Bone Therapeutics’ Osteoarthritis Programme; JandJ’s HIV Vaccine Trial; Versanis Bio $70 M Series A Financing; AC Immune’s Alzheimer’s Antibody Drug Read More »

EMA looks at booster data for Pfizer/BioNTech COVID-19 jab

The EU regulator has started to review a marketing application filed by Pfizer and BioNTech for a third, booster dose of their Comirnaty COVID-19 vaccine given six months after the first course to people aged 16 and over. The EMA’s CHMP human medicines committee will carry out an accelerated review of the application, which comes …

EMA looks at booster data for Pfizer/BioNTech COVID-19 jab Read More »

Australian Novavax trial participants remain unrecognised by vaccine register

Covid vaccination status of hundreds in limbo because the US company’s jab is yet to be approved in Australia Vaccine rollout tracker; get our free news app; get our morning email briefing Australians who participated in clinical trials of the Novavax Covid vaccine are being told their vaccinations cannot currently be recognised on Australia’s immunisation …

Australian Novavax trial participants remain unrecognised by vaccine register Read More »

PharmaShots Weekly Snapshots (August 30 – September 03, 2021)

Forte’s FB-401 Fails to Meet Primary Endpoints in P-II Clinical Trial For the Treatment of Atopic Dermatitis Published: Sept 3, 2021 | Tags: Forte, FB-401, P-II, Clinical Trial, Atopic Dermatitis Novartis Cosentyx (secukinumab) Receives NICE Recommendation for Patients with Plaque Psoriasis Published: Sept 3, 2021 | Tags: Novartis, Cosentyx, secukinumab, NICE Recommendation, Plaque Psoriasis Pfizer …

PharmaShots Weekly Snapshots (August 30 – September 03, 2021) Read More »

PharmaShots Weekly Snapshots (August 30 – September 03, 2021)

Forte’s FB-401 Fails to Meet Primary Endpoints in P-II Clinical Trial For the Treatment of Atopic Dermatitis Published: Sept 3, 2021 | Tags: Forte, FB-401, P-II, Clinical Trial, Atopic Dermatitis Novartis Cosentyx (secukinumab) Receives NICE Recommendation for Patients with Plaque Psoriasis Published: Sept 3, 2021 | Tags: Novartis, Cosentyx, secukinumab, NICE Recommendation, Plaque Psoriasis Pfizer …

PharmaShots Weekly Snapshots (August 30 – September 03, 2021) Read More »

Pfizer raises pressure on GSK, J&J with late-stage RSV vaccine trial

Pfizer has vaulted ahead with its respiratory syncytial virus (RSV) vaccine, closing the gap with GlaxoSmithKline and Johnson & Johnson as the companies strive to bring the first licensed shot to market. The first of an anticipated 30,000 subjects have been vaccinated in Pfizer’s phase 3 RENOIR trial of its vaccine, just behind GSK and …

Pfizer raises pressure on GSK, J&J with late-stage RSV vaccine trial Read More »

FDA schedules adcomm for Pfizer’s COVID booster filing

The FDA has said it will hold an advisory committee meeting later this month to discuss Pfizer and BioNTech’s filing for approval of a third booster dose of their COVID-19 vaccine Comirnaty in people aged 16 and over. The adcomm is scheduled for 17 September and will discuss the Pfizer/BioNTech filing as well as booster …

FDA schedules adcomm for Pfizer’s COVID booster filing Read More »

FDA firms up JAK inhibitor warnings after Xeljanz review

The FDA has concluded its safety review of Pfizer’s JAK inhibitor Xeljanz and Xeljanz XR, requiring revised warnings for the drugs as well as others in the class after finding evidence of elevated risks of serious heart-related events. After looking at the data from Pfizer’s long-term, post-marketing safety study – ORAL Surveillance – the US …

FDA firms up JAK inhibitor warnings after Xeljanz review Read More »

FDA cracks down on JAK drug class, calls for new warnings of heart, cancer risks

The FDA’s review of a post-marketing study for Pfizer blockbuster anti-inflammatory drug Xeljanz found a higher risk of cardiovascular problems and cancer, and the agency is requiring additional warnings flagging those risks. The updated warnings extend to AbbVie and Eli Lilly medicines in the same drug class.

Real-world study suggest AI may improve atrial fibrillation screening

An artificial intelligence algorithm already shown to be able to detect atrial fibrillation (AF) in clinical testing has also shown its worth in a real-world setting, according to its developers. The AI – developed by the Bristol Myers Squibb-Pfizer Alliance on cardiovascular disease – was developed using machine learning from a UK dataset of almost …

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Pfizer eczema contender beats Dupixent in study, but JAK drug class is still in limbo

Pfizer has preliminary data showing its experimental drug for atopic dermatitis beat a blockbuster drug from Regeneron Pharmaceuticals in a head-to-head clinical trial. But the future of that drug and others might depend more on an FDA review of safety data for medicines in this class of so-called JAK inhibitors.

Pfizer Reports Results of Abrocitinib in P-III JADE DARE Study to Treat Atopic Dermatitis

Shots: The head-to-head P-III JADE DARE study involves assessing the efficacy of Abrocitinib (200mg, qd, PO) vs dupilumab (300mg, SC, q2w followed by 600mg induction dose) in adult patients on background topical therapy with moderate to severe AD The study met its co-1EPs of at least a 4-point improvement in the severity of PP-NRS4 @2wks. …

Pfizer Reports Results of Abrocitinib in P-III JADE DARE Study to Treat Atopic Dermatitis Read More »

PharmaShots Weekly Snapshots (August 23 – 27, 2021)

Ascendis’ Skytrofa (lonapegsomatropin-tcgd) Receives the US FDA’s Approval for Pediatric Growth Hormone Deficiency Published: Aug 27, 2021 | Tags: Ascendis, Skytrofa, lonapegsomatropin-tcgd, US, FDA, Approval, Pediatric Growth Hormone Deficiency Amgen Presents Results of Repatha (evolocumab) in P-III HUYGENS Study for the Treatment of Acute Coronary Syndrome at ESC 2021 Published: Aug 27, 2021 | Tags: …

PharmaShots Weekly Snapshots (August 23 – 27, 2021) Read More »

Merck raises pressure on Pfizer in pneumococcal vaccine tussle

Just a month after getting approval for its new pneumococcal vaccine Vaxneuvance in adults, Merck & Co has reported positive trial results in children that will ramp up the pressure on Pfizer and its market-leading Prevnar franchise. The 15-valent conjugate vaccine was at least as effective as Pfizer’s 13-valent Prevnar 13 in the study, which …

Merck raises pressure on Pfizer in pneumococcal vaccine tussle Read More »

UK real-world study finds COVID-19 jab protection wanes

A study has found evidence that protection from the AstraZeneca and Pfizer/BioNTech COVID-19 vaccines starts fall off after a few months, but a UK government advisor says there’s no need to rush into a large-scale booster campaign. The results of the ZOE COVID study found that initial protection against infection a month after the second …

UK real-world study finds COVID-19 jab protection wanes Read More »

Top 7 Pharma Industry Leaders in 2020 By the Numbers

Pharmaceutical companies play a vital part in our lives and in helping us to live healthier lives. The pharmaceutical industry finds, develops, manufactures, and promotes medicines or pharmaceutical drugs for usage as medications that are administered (or self-administered) to patients in order to cure, vaccinate, or relieve symptoms. Pharmaceutical companies may deal in both generic …

Top 7 Pharma Industry Leaders in 2020 By the Numbers Read More »

Pfizer makes big move in blood cancers with $2.3B Trillium acquisition

Though Gilead Sciences leads the group of companies developing immunotherapies that target the cancer protein CD47, Pfizer contends that molecules it is getting through the Trillium Therapeutics acquisition have safety and efficacy advantages that could make them the best in this emerging drug class.

Pfizer, BioNTech Covid-19 vaccine is awarded full FDA approval

Full FDA approval makes the Pfizer/BioNTech Covid-19 vaccine the first to reach that milestone. But the regulatory decision also flagged a potential risk of heart inflammation, particularly in young males, and the agency has asked the companies to conduct additional clinical research.

FDA grants full approval to Pfizer/BioNTech COVID jab

Pfizer and BioNTech’s COVID-19 vaccine was the first to get emergency use authorisation (EUA) from the FDA, and has also become the first to get full regulatory approval in the US. The regulator has cleared the vaccine – now officially given the trade name Comirnaty – to prevent COVID-19 in people aged 16 or more, …

FDA grants full approval to Pfizer/BioNTech COVID jab Read More »

Pfizer vaults into CD47 arena, buying Trillium for $2.3 billion

Pfizer is the latest big pharma company to take a position on drugs that target CD47 – a ‘don’t eat me’ signal that protects cancer cells from being attacked by the immune system. The drugmaker has agreed a $2.3 billion deal to buy Canadian biotech Trillium Therapeutics and its two lead candidates – TTI-622 and …

Pfizer vaults into CD47 arena, buying Trillium for $2.3 billion Read More »

Pfizer to Acquire Trillium for ~$2.26B

Shorts: Pfizer will acquire all outstanding shares of Trillium for $18.50/share in cash making a total equity value of $2.26B with 203.8% premium on the stock’s last closing price The acquisition will bolster Pfizer’s R&D capabilities & accelerates clinical development of Trillium’s SIRPα fusion proteins i.e., TTI-622 & TTI-621 that are currently in P-Ib/II trial …

Pfizer to Acquire Trillium for ~$2.26B Read More »

Pfizer’s Xeljanz (tofacitinib citrate) Receives EC’s Approval for the Treatment of Active Polyarticular JIA & Juvenile PsA

Shots: The approval is based on a P-III study which includes 2 phases i.e., run-in & withdrawal phase evaluating efficacy & safety of tofacitinib (5mg tablet or mg/mL oral solution, BID) in 398 patients aged ≥2yrs. with polyarticular JIA & juvenile PsA who have had an inadequate response to previous therapy with DMARDs for 44wks. …

Pfizer’s Xeljanz (tofacitinib citrate) Receives EC’s Approval for the Treatment of Active Polyarticular JIA & Juvenile PsA Read More »

PharmaShots Weekly Snapshots (August 16 – 20, 2021)

Janssen Presents Results of Rybrevant (amivantamab-vmjw) in P-I CHRYSALIS Study for Advanced NSCLC with METex14 Mutations at WCLC Published: Aug 20, 2021 | Tags: Astellas, FibroGen, Evrenzo, Roxadustat, EC, Approval, Symptomatic Anemia, Chronic Kidney Disease Astellas and FibroGen’s Evrenzo (roxadustat) Receive EC’s Approval for Symptomatic Anemia Associated with Chronic Kidney Disease Published: Aug 20, 2021 …

PharmaShots Weekly Snapshots (August 16 – 20, 2021) Read More »

Years after Pfizer merger, ex-Medivation exec gets insider trading charge

A Medivation executive at the heart of the company’s team that sold the company to Pfizer for $14 billion five years ago is facing allegations of insider trading. Matthew Panuwat A complaint filed by the US Securities and Exchange Commission (SEC) today accuses Matthew Panuwat, the then-head of business development at Medivation, of buying sizeable …

Years after Pfizer merger, ex-Medivation exec gets insider trading charge Read More »

Pfizer, BioNTech file for FDA approval of COVID booster shot

Pfizer and BioNTech have formally asked for FDA approval of a third dose of their COVID-19 vaccine BNT162b2 in people aged over 16, as the US prepares to get its booster campaign underway. The two companies have submitted data from a phase 1 trial in support of the booster dose to the US regulator, and …

Pfizer, BioNTech file for FDA approval of COVID booster shot Read More »

Drug firms poised to make billions of dollars from Covid booster jabs

Sales of BioNTech, Moderna and Pfizer drugs could rival $6bn-a-year market for flu vaccines, say analysts Coronavirus – latest updates See all our coronavirus coverage The drug companies Pfizer, BioNTech and Moderna are poised to make billions of dollars from Covid-19 booster jabs this autumn, with analysts estimating that sales could rival the $6bn-a-year market …

Drug firms poised to make billions of dollars from Covid booster jabs Read More »

FDA authorizes Covid-19 booster shots, but only for the immunocompromised

Covid-19 vaccine booster shots are now authorized for organ transplant patients and others who have weakened immune systems. The FDA based its update on the results of two small studies that tested third shots of the mRNA Covid vaccines from Moderna and Pfizer/BioNTech.

FDA authorises COVID booster jabs for at-risk people

The FDA has cleared the use of third dose of either the Pfizer/BioNTech or Moderna COVID-19 vaccines for people with weakened immune systems, but stopped short of a broader booster campaign. The emergency use authorisation (EUA) for the two mRNA-based vaccines has been amended so they can be used for solid organ transplant recipients or …

FDA authorises COVID booster jabs for at-risk people Read More »

Top 20 Immunology Companies Based on 2020 Immunology Segment Revenue

Immunology deals with physiological functioning of the immune system in states of both health and disease as well as malfunctions of the immune system in immunological disorders With the new advancement in immune sector, global pharmaceuticals continue to grow in the field despite the disruption during the COVID-19. As in 2019, Abbvie again secured the …

Top 20 Immunology Companies Based on 2020 Immunology Segment Revenue Read More »

UK cues up more Pfizer/BioNTech vaccines as price row looms

The UK government has started ordering COVID-19 vaccines for a 2022 booster campaign, including a 32 million-dose order for the Pfizer/BioNTech shot, even before third doses for 2021 have been given the go-ahead. A report in The Times claims that the government is paying £22 a dose – up from an earlier price of £18 …

UK cues up more Pfizer/BioNTech vaccines as price row looms Read More »

Covid-19 vaccines: the contracts, prices and profits

Raised charges and Covax deals on order books of Pfizer, BioNTech, Moderna and AstraZeneca Coronavirus – latest updates See all our coronavirus coverage Two US companies, Pfizer and Moderna, have raised the prices of their Covid-19 vaccines after data from clinical trials showed their mRNA formula was more effective than cheaper vaccines from Britain’s AstraZeneca …

Covid-19 vaccines: the contracts, prices and profits Read More »

UK orders extra Covid vaccines for autumn 2022 booster campaign

Pfizer reportedly asked to supply 35m more doses, with final go-ahead for this year’s programme still awaited Coronavirus – latest updates See all our coronavirus coverage Ministers have started ordering vaccines for a booster campaign in autumn 2022, with Pfizer reportedly being asked to supply the UK with a further 35m doses. The government has …

UK orders extra Covid vaccines for autumn 2022 booster campaign Read More »

HIMSS Digital: Future is bright for payer-provider-pharma collaboration

The pandemic made collaboration necessary between stakeholders that otherwise tend to be at odds with each other. But as partnerships grow, providers, payers and pharma companies must ensure they are working toward a clear-cut common goal, according to panelists at HIMSS 21 Digital.

BioNTech says repeat doses may be better than modified COVID-19 jab

BioNTech has suggested that giving booster doses of its current Comirnaty (BNT162b2) COVID-19 vaccine may be a preferable strategy to modifying the Pfizer-partnered shot. The comments came on the German biotech’s second-quarter results call, during which BioNTech raised its forecasts for revenues it will book from sales of the vaccine to €15.9 billion (almost $19 …

BioNTech says repeat doses may be better than modified COVID-19 jab Read More »

Scotland backs Bavencio for bladder cancer after NICE says no

Patients with bladder cancer in Scotland will be the first in the UK to claim access to maintenance treatment with Merck Serono and Pfizer’s Bavencio, ahead of their counterparts in England and Wales. The Scottish Medicines Consortium (SMC) has cleared NHS funding for Bavencio (avelumab) as a first-line maintenance therapy for people with advanced urothelial …

Scotland backs Bavencio for bladder cancer after NICE says no Read More »

PharmaShots Weekly Snapshots (Aug 02 – 06, 2021)

Medtronic to Acquire Intersect ENT for ~$1.1B Published: Aug 6, 2021 | Tags: Medtronic, Intersect ENT, ~$1.1B Kite Signs a License Agreement with Appia to Develop Allogeneic Cell Therapies for the Treatment of Cancer Published: Aug 6, 2021 | Tags: Kite, Appia, Allogeneic Cell Therapies, Cancer Polpharma & Bioeq Report BLA Submission to the US …

PharmaShots Weekly Snapshots (Aug 02 – 06, 2021) Read More »

Pfizer, Flynn in the firing line again over UK epilepsy drug pricing

The UK’s Competition and Markets Authority (CMA) has resurrected a complaint against Pfizer and Flynn Pharma, claiming the two companies charged the NHS excessive prices for a widely-used epilepsy therapy. In a provisional judgment, the CMA has concluded that Pfizer and Flynn abused a dominant position to overcharge the NHS for phenytoin sodium capsules, causing …

Pfizer, Flynn in the firing line again over UK epilepsy drug pricing Read More »

Pfizer and Flynn accused of overcharging NHS for anti-epilepsy drugs

Competition regulator the CMA alleges drugs firms abused dominant position with unfairly high prices Pharmaceutical companies Pfizer and Flynn have been accused by the UK’s competition watchdog of illegally overcharging the NHS for vital anti-epilepsy drugs by abusing their dominance in the market to raise prices overnight. The Competition and Markets Authority (CMA) has confirmed …

Pfizer and Flynn accused of overcharging NHS for anti-epilepsy drugs Read More »

Lilly has a bad hair day as Pfizer rival hits the mark in alopecia

Eli Lilly and Incyte have another rival in the rear-view mirror for Olumiant in alopecia areata after Pfizer reported that its ritlecitinib improved scalp hair regrowth in a late-stage trial. In the phase 2b/3 ALLEGRO trial, JAK inhibitor ritlecitinib hit its primary objective of improving the area of scalp covered by hair in people with …

Lilly has a bad hair day as Pfizer rival hits the mark in alopecia Read More »

UK extends COVID vaccination to 16 and 17-year-olds

The UK government has confirmed that the national COVID-19 vaccination campaign will be extended to include 16 and 17-year-old children, to tackle an increase in spread of the virus in younger age groups. The moves comes on the back of new advice from the Joint Committee on Vaccine and Immunisation (JCVI), which has concluded that …

UK extends COVID vaccination to 16 and 17-year-olds Read More »

Germany confirms booster COVID jabs will start in September

Germany’s health ministry has said it will start offering booster COVID-19 vaccines to vulnerable people from next month, amid concerns about rising cases of the delta variant of the coronavirus. Health Minster Jens Spahn said the decision was also taken because of concerns that the immune response stimulated by COVID-19 vaccines may start to diminish …

Germany confirms booster COVID jabs will start in September Read More »

As Delta spreads, Pfizer and Moderna get set for a booster shot to profits

The firms are already taking the lion’s share of earnings from the market, as this week’s results will show Praised for preventing hundreds of thousands of deaths and allowing a return to more normal life, Covid vaccines will also substantially benefit some pharmaceutical companies. In June, analysts estimated the global market for the vaccines could …

As Delta spreads, Pfizer and Moderna get set for a booster shot to profits Read More »

AstraZeneca sales of Covid vaccine triple to $1.2bn in first half of 2021

Not-for-profit pledge sees British firm’s sales revenue fall significantly short of US rival Pfizer Coronavirus – latest updates See all our coronavirus coverage AstraZeneca’s Covid-19 vaccine has brought in $1.2bn (£900m) in the first half of this year, with sales tripling in the second quarter from the first – but its earnings remained significantly below …

AstraZeneca sales of Covid vaccine triple to $1.2bn in first half of 2021 Read More »

Major delay in federal government’s Novavax deal, with 51m doses not expected until 2022

Initially touted as a ‘primary’ vaccine to help immunise Australia by the end of this year, Novavax will now form part of the booster strategy One of the federal government’s key vaccine deals has been hit with major delays, with 51 million doses of Novavax originally due to arrive in the second half of this …

Major delay in federal government’s Novavax deal, with 51m doses not expected until 2022 Read More »

Study finds jabs cut severe variant COVID disease after one shot

A real-world study carried out in Canada had found that COVID-19 vaccines from AstraZeneca, Pfizer/BioNTech and Moderna reduce the chances of being hospitalised or dying from variants of concern dramatically, even after a single dose. AstraZeneca’s Vaxzevria was found to 87% effective after against the delta variant, which is now thought to be one of …

Study finds jabs cut severe variant COVID disease after one shot Read More »

Pfizer commits $1B to Arvinas for share of protein degrading breast cancer drug

Arvinas’ early clinical data for its targeted protein degradation drug for breast cancer drew partnering interest from several companies. Pfizer beat them all with a deal that pays the biotech $1 billion to share in the development and commercialization of this therapy.

Pfizer puts up $1bn to buy into Arvinas breast cancer programme

Pfizer has pledged a whopping $11 billion upfront for rights to an Arvinas drug for breast cancer from its protein degrader platform, which harnesses cells’ natural protein-denaturing machinery to remove rogue proteins associated with disease. The deal focuses on ARV-471, currently in phase 2 testing for advanced breast cancer patients whose tumours expresses oestrogen receptors …

Pfizer puts up $1bn to buy into Arvinas breast cancer programme Read More »

FDA okays Merck’s would-be Prevnar rival Vaxneuvance

The FDA has approved a new pneumococcal vaccine from Merck & Co, just over a month after Pfizer got a green light for a new version of its market leading Prevnar shot. Merck’s Vaxneuvance – formerly known as V114 – is the first major competition to Pfizer’s franchise in the big market for conjugate pneumococcal …

FDA okays Merck’s would-be Prevnar rival Vaxneuvance Read More »

Shot in the arm for Affinivax as it challenges Pfizer’s Prevnar

Already facing one rival to its blockbuster pneumococcal vaccine Prevnar, Pfizer could have another to contend with, after Affinivax reported positive phase 2 results with its ASP3772 candidate – plus a new breakthrough designation from the FDA. Last year, Pfizer made almost $6 billion from its Prevnar 13 vaccine, which covers 13 common serotypes of …

Shot in the arm for Affinivax as it challenges Pfizer’s Prevnar Read More »

US officials call for more data on vaccine boosters as Pfizer pushes for third shot

• Pharma company presses case with senior health officials • WHO urges priority for nations with low Covid vaccination rates Pfizer, the pharmaceutical company that created one of the first Covid-19 vaccines to be approved, has been making a hard sell for emergency approval of boosters – additional doses given to those already vaccinated, especially …

US officials call for more data on vaccine boosters as Pfizer pushes for third shot Read More »

Pfizer pushes for booster shots as WHO says greed is driving vaccine disparities

• Pharmaceutical company seeks FDA approval for third dose • Companies urged to instead prioritise less wealthy countries After a sharp increase in US Covid cases and amid fears of a surge of the Delta variant, Pfizer on Monday said it was seeking federal authorisation for third doses of its Covid-19 vaccine to be delivered …

Pfizer pushes for booster shots as WHO says greed is driving vaccine disparities Read More »

Morrison government silent on contact with Pfizer global chief after Kevin Rudd intervenes in vaccine talks

Under fire for his government not reaching out to the pharmaceutical giant’s international head, health minister Greg Hunt also avoided naming the former Labor PM Scott Morrison and federal health minister Greg Hunt have not denied claims that they failed to press Australia’s case for more vaccine doses directly with Pfizer’s global chief, after revelations …

Morrison government silent on contact with Pfizer global chief after Kevin Rudd intervenes in vaccine talks Read More »

Eyeing delta surge, Pfizer will file COVID-19 booster next month

With the COVID-19 delta variant has become the dominant strain circulating in the US, Pfizer and BioNTech have said they will ask the FDA and other regulators to approve a third dose of their Comirnaty vaccine to guard against a winter surge in cases.  The two companies have revealed data from an ongoing trial of …

Eyeing delta surge, Pfizer will file COVID-19 booster next month Read More »

Israel says Pfizer jab less effective against COVID-19 delta

The Israeli Ministry of Health has reported data suggesting that the efficacy of the Pfizer/BioNTech COVID-19 vaccine has become less effective at preventing the spread of the coronavirus after the emergence of the delta variant. The vaccine still seems to be able to prevent hospitalisation and severe cases of COVID-19, but its efficacy in preventing …

Israel says Pfizer jab less effective against COVID-19 delta Read More »

Spero Therapeutics Enters into a License Agreement with Pfizer for SPR206 to Treat MDR Gram Negative Infections

Shots: Spero is eligible to receive $40M as an equity investment and ~$80M as development & sales milestones along with royalties on sales of SPR206 in licensed countries. Pfizer gets rights to develop, manufacture & commercialize SPR206 in ex-US & ex-Asia As per the 2019 licensing agreement with Spero, Everest Medicines has exclusive rights to …

Spero Therapeutics Enters into a License Agreement with Pfizer for SPR206 to Treat MDR Gram Negative Infections Read More »

Million Pfizer jabs face being dumped after Israel-UK swap deal fails

Israel says technical issues have scuppered deal to give UK Covid vaccines expiring on 30 July Coronavirus – latest updates See all our coronavirus coverage More than a million Pfizer/BioNTech vaccine doses held in Israel that are due to expire at the end of July may be thrown away after attempts to broker a swap …

Million Pfizer jabs face being dumped after Israel-UK swap deal fails Read More »

PharmaShots’ Key Highlights of Second Quarter 2021

The second quarter of 2021 witnesses major acquisitions, approvals, and clinical data. There are major alliances in this quarter which include Merck signed ~$1.2B supply agreement with US Government for Molnupiravir to treat COVID-19 The big acquisition took place during the quarter including Microsoft acquired Nuance for ~$19.7B, MorphoSys acquired Constellation for ~$1.7B Our team …

PharmaShots’ Key Highlights of Second Quarter 2021 Read More »

Moderna, Pfizer or AstraZeneca? The ridiculous, diverting rise of vaccine envy

Casual vaccine chat is today’s only form of small talk, so it’s not surprising it would take a lightheartedly tribal turn. Ultimately, of course, gratitude is at the heart of the conversation Last week, I had cause to go searching for images of men getting vaccinated (it’s not a fetish – it was for work) …

Moderna, Pfizer or AstraZeneca? The ridiculous, diverting rise of vaccine envy Read More »

Covid jabs for billions of humans will earn their makers billions of dollars

We look at the drug firms – led by Pfizer and Moderna – that are set to profit most in an unprecedented global vaccination drive Coronavirus – latest updates See all our coronavirus coverage Drugmakers led by US firms Pfizer and Moderna stand to make tens of billions of dollars from their Covid-19 vaccines this …

Covid jabs for billions of humans will earn their makers billions of dollars Read More »

PharmaShots Weekly Snapshots (June 14 – 18, 2021)

Lineage Signs an Exclusive Option Agreement with Amasa Therapeutics to Supply and Use of Clinical-Grade Hystem Published: June 18, 2021 | Tags: Lineage, Option Agreement, Amasa Therapeutics, Clinical-Grade Hystem BioNTech Reports First Patient Dosing in P-II Clinical Trial of BNT111 to Treat Advanced Melanoma Published: June 18, 2021 | Tags: BioNTech, P-II, Clinical Trial, BNT111, …

PharmaShots Weekly Snapshots (June 14 – 18, 2021) Read More »

Pfizer Presents Results of Tofacitinib in STOP-COVID Study for Patients Hospitalized with COVID-19 Pneumonia at NEJM

Shots: The STOP-COVID study was conducted with a research collaboration b/w Pfizer & an ARO in Brazil, evaluating the efficacy & safety of tofacitinib (10mg, bid) + SoC vs PBO + SoC in a ratio (1:1) in 289 hospitalized patients with COVID-19 pneumonia who were not on ventilation for 14 days or until hospital discharge …

Pfizer Presents Results of Tofacitinib in STOP-COVID Study for Patients Hospitalized with COVID-19 Pneumonia at NEJM Read More »

PharmaShots Weekly Snapshots (June 07 – 11, 2021)

Vertex and CRISPR Therapeutics Present New Data of CTX001 from 22 Patients with TDT and SCD at EMA 2021 Published: June 11, 2021 | Tags: Vertex, CRISPR Therapeutics, CTX001, TDT, SCD, EMA 2021 AbbVie Reports Results of Four-Year Follow-Up Analysis in P-III CLL14 Trial for Venclyxto/Venclexta to Treat Chronic Lymphocytic Leukemia Published: June 11, 2021 …

PharmaShots Weekly Snapshots (June 07 – 11, 2021) Read More »

US orders 500m Pfizer/BioNTech COVID jabs for developing nations

The US government will buy 500 million more doses of the Pfizer/BioNTech COVID-19 vaccine that will be given to around 100 countries via the COVAX donation programme over the next two years. Pfizer and BioNTech are providing 200 million doses this year, and another 300 million in the first half of 2022, at a not-for-profit …

US orders 500m Pfizer/BioNTech COVID jabs for developing nations Read More »

Pfizer’s Prevnar 20 wins FDA nod, getting edge in pneumococcus vax race—for now

The FDA has approved Prevnar 20, a Pfizer vaccine that protects against 20 pneumococcal strains—seven more than the company’s blockbuster Prevnar 13. But others are on Pfizer’s heels with vaccine candidates that aim to match or even beat the Pfizer pneumococcal vaccines.

FDA clears Pfizer’s Prevnar 20 for adults, as Merck rival nears decision

Pfizer has the FDA approval it was seeking for Prevnar 20, the latest update to its blockbuster pneumococcal vaccination franchise, keeping it one step ahead of a competing shot from Merck & Co. The US regulator has cleared the pneumococcal conjugate vaccine – which protects against 20 common strains of Streptococcus pneumoniae – for adults …

FDA clears Pfizer’s Prevnar 20 for adults, as Merck rival nears decision Read More »

Pfizer’s Prevnar 20 (Pneumococcal 20-Valent Conjugate Vaccine) Receives the US FDA’s Approval for the Prevention of Invasive Disease and Pneumonia

Shots: The approval is based in the clinical program including P-I & II trials, and three P-III trials evaluating the safety & immunogenicity of Prevnar 20 in adults aged ≥18yrs. with invasive disease and pneumonia caused by the 20 S. pneumoniae serotypes This is the first approval of a vaccine that protects against 20 serotypes …

Pfizer’s Prevnar 20 (Pneumococcal 20-Valent Conjugate Vaccine) Receives the US FDA’s Approval for the Prevention of Invasive Disease and Pneumonia Read More »

PharmaShots Weekly Snapshots (May 31 – June 4, 2021)

Tonix Pharmaceuticals Presents Results of TNX-102 SL in P-III RELIEF study for the Management of Fibromyalgia at ASCP 2021 Published: June 4, 2021 | Tags: Tonix Pharmaceuticals, TNX-102 SL, P-III, RELIEF Study, Fibromyalgia, ASCP 2021 Dermavant Submits NDA to the US FDA for Tapinarof Cream to Treat Plaque Psoriasis Published: June 4, 2021 | Tags: …

PharmaShots Weekly Snapshots (May 31 – June 4, 2021) Read More »

Fears of side-effects fuel reluctance to get Covid jabs, survey finds

Imperial College London survey in 15 countries also reveals worries that vaccines had not been tested enough Coronavirus – latest updates See all our coronavirus coverage Most people who are reluctant to be vaccinated against Covid are worried about side-effects and whether the vaccines have been adequately tested, a survey in 15 countries has shown. …

Fears of side-effects fuel reluctance to get Covid jabs, survey finds Read More »

Pfizer and BioNTech Receive EC’s Conditional Marketing Approval for the COVID-19 Vaccine in Adolescents

Shots: The approval is based on a P-III study assessing Comirnaty (two 30μg doses) in 2,260 participants aged 12-15yrs. and showed 100% efficacy in participants with/out prior SARS-CoV-2 infection, robust Ab responses and was well tolerated The approval follows CHMP’s positive opinion to authorize the vaccine in this group. The extended indication for the CMA …

Pfizer and BioNTech Receive EC’s Conditional Marketing Approval for the COVID-19 Vaccine in Adolescents Read More »

PharmaShots Weekly Snapshots (May 24 – 28, 2021)

Seelos’ SLS-005 (Trehalose) Receives EC’s Orphan Drug Designation to Treat Amyotrophic Lateral Sclerosis Published: May 28, 2021 | Tags: Seelos, SLS-005, Trehalose, EC, Orphan Drug Designation,  Amyotrophic Lateral Sclerosis The US FDA’s EMDAC Supports Provention Bio’s Teplizumab in Delaying Diabetes Published: May 28, 2021 | Tags: US, FDA, EMDAC, Provention Bio, Teplizumab, Delaying Diabetes uniQure …

PharmaShots Weekly Snapshots (May 24 – 28, 2021) Read More »

Chasing Lilly, Concert eyes 2023 filing for its JAK drug for alopecia

Concert Pharmaceuticals has started the second of two planned phase 3 trials of its drug candidate for alopecia areata (AA), a common cause of hair loss, and says it hopes to report results in the second half of 2022. The two studies – THRIVE-AA1 and THRIVE-AA2 – are testing oral JAK1/2 inhibitor CTP-543 in adults …

Chasing Lilly, Concert eyes 2023 filing for its JAK drug for alopecia Read More »

FDA clears Myovant’s relugolix for uterine fibroids, setting up AbbVie clash

Myovant has chalked up a second approval for its flagship drug relugolix from the FDA, becoming the first once-daily oral drug in the US to treat heavy menstrual bleeding associated with uterine fibroids.  The drug will be sold as Myfembree (relugolix) for the uterine fibroids indication, and is already available to treat prostate cancer under …

FDA clears Myovant’s relugolix for uterine fibroids, setting up AbbVie clash Read More »

Pfizer and Myovant’s Myfembree Receive the US FDA’s Approval for Heavy Menstrual Bleeding Associated with Uterine Fibroids

Shots: The approval is based on efficacy and safety data from the P-III LIBERTY 1 & 2 studies assessing Myfembree (relugolix 40 mg, estradiol 1 mg & norethindrone acetate 0.5 mg) vs PBO for heavy menstrual bleeding associated with uterine fibroids in premenopausal women with a treatment duration for up to 2yrs. The P-III studies …

Pfizer and Myovant’s Myfembree Receive the US FDA’s Approval for Heavy Menstrual Bleeding Associated with Uterine Fibroids Read More »

Moderna will file COVID-19 jab for teens after trial shows 100% protection

Moderna’s COVID-19 vaccine has joined the Pfizer/BioNTech jab in showing efficacy in younger patients in clinical trials, setting up an emergency use filing early next month. The results of the phase 2/3 TeenCOVE study in more than 3,700 adolescents aged 12 to 17 revealed no cases of COVID-19 after two doses of the mRNA-1273 shot, …

Moderna will file COVID-19 jab for teens after trial shows 100% protection Read More »

Moderna jab stops Covid transmission in people aged 12 to 18, trial finds

Moderna becomes second manufacturer to announce successful trial results in younger people Coronavirus – latest updates See all our coronavirus coverage Mass vaccination of children against Covid-19 moved a step closer as Moderna became the second manufacturer to announce successful trial results, showing its vaccine can stop transmission in people aged 12 to 18. Pfizer/BioNTech’s …

Moderna jab stops Covid transmission in people aged 12 to 18, trial finds Read More »

Safety of mRNA COVID-19 jabs backed, despite myocarditis cases

As US and EU health regulators review cases of heart inflammation seen in young people administered mRNA-based COVID-19 vaccines from Pfizer/BioNTech and Moderna, cardiologists have come out in favour of the jabs. The American Heart Association (AHA) and American Stroke Association (ASA) have issued a statement saying that the benefits of the vaccines “enormously outweigh …

Safety of mRNA COVID-19 jabs backed, despite myocarditis cases Read More »

Pfizer Initiates Study to Evaluate its Pneumococcal Vaccine with Booster dose of its COVID-19 Vaccine

Shots: The first enrolled patient has received their immunizations as part of a new study in adults ≥65yrs. evaluating the coadministration of 20vPnC with a booster dose of the Pfizer-BioNTech’s COVID-19 vaccine The trial will include ~600 adults who will be recruited from the P-III COVID-19 vaccine trial and will have received their second dose …

Pfizer Initiates Study to Evaluate its Pneumococcal Vaccine with Booster dose of its COVID-19 Vaccine Read More »

UK says Pfizer, AZ COVID-19 vaccines work against Indian variant

People who have received two doses of the AstraZeneca or Pfizer/BioNTech COVID-19 vaccines have good protection against the Indian variant of SARS-CoV-2 , according to new UK data. The Pfizer/BioNTech shot provided 88% protection against the B.1.617.2 variant first identified in India and currently gaining ground across the UK and other countries around the world, …

UK says Pfizer, AZ COVID-19 vaccines work against Indian variant Read More »

UK booster trial will test value of third COVID jab dose

All seven COVID-19 vaccines ordered by the UK government will be tested in a new trial that will see whether they can be used as a third booster dose to protect against new variants.  The Cov-Boost trial is thought to be the first in the world to try to generate data on the value of …

UK booster trial will test value of third COVID jab dose Read More »

PharmaShots Weekly Snapshots (May 10 – 14, 2021)

AzurRx BioPharma Reports Positive Interim P-II Data of MS1819 + PERT for Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency Published: May 14, 2021 | Tags: AzurRx BioPharma, P-II, MS1819, PERT, Cystic Fibrosis, Severe, Exocrine Pancreatic Insufficiency Goldfinch Bio Initiates P-I Clinical Trial of GFB-024 for the Treatment of Severe Insulin Resistant Diabetic Nephropathy Published: …

PharmaShots Weekly Snapshots (May 10 – 14, 2021) Read More »

Delay in giving second jabs of Pfizer vaccine improves immunity

Study finds antibodies against Sars-CoV-2 three-and-a-half times higher in people vaccinated again after 12 weeks rather than three Coronavirus – latest updates See all our coronavirus coverage The UK’s decision to delay second doses of coronavirus vaccines has received fresh support from research on the over-80s which found that giving the Pfizer/BioNTech booster after 12 …

Delay in giving second jabs of Pfizer vaccine improves immunity Read More »

First UK patient joins Pfizer’s phase 3 DMD gene therapy trial

The first UK patient has enrolled on Pfizer’s phase 3 trial for its Duchenne muscular dystrophy (DMD) gene therapy. Pfizer’s CIFFREO study began in the US in January this year and has now begun enrolling eligible patients in the UK. The first patient was recruited in The Newcastle upon Tyne Hospitals NHS Foundation Trust, one …

First UK patient joins Pfizer’s phase 3 DMD gene therapy trial Read More »

Pfizer warns Australia a Covid vaccine patent waiver could harm supply and safety

The pharmaceutical giant argues waiving intellectual property protections could see scarce inputs snapped up making it harder to produce vaccines Full Story podcast: Is Australia stopping the world’s poorest nations from accessing cheap vaccines? What is patent waiving and will it solve the global shortage? Pfizer has warned Australia against joining a growing push to …

Pfizer warns Australia a Covid vaccine patent waiver could harm supply and safety Read More »

FDA authorises Pfizer/BioNTech vaccine for adolescents

The FDA has authorised Pfizer/BioNTech’s vaccine for 12- to 15 year-olds under emergency rules. In a statement the regulator said it had expanded the vaccine’s Emergency Use Authorization to include the new age group. The vaccine was first approved under the emergency protocols on 11th December, for people aged 16 years of age and older. …

FDA authorises Pfizer/BioNTech vaccine for adolescents Read More »

Pfizer and BioNTech Receive the US FDA’s EMA for COVID-19 Vaccine in Adolescents

Shots: The FDA has expanded the EUA for Pfizer’s COVID-19 vaccine in adolescents based on the data from the P- III trial in 2,260 participants aged 12-15yrs. which showed 100% efficacy and was well-tolerated. The submission of data in children aged 6mos.- 2yrs. are expected in Q4’21 The companies have submitted the data in adolescents …

Pfizer and BioNTech Receive the US FDA’s EMA for COVID-19 Vaccine in Adolescents Read More »

EMA panel probes heart inflammation with Pfizer/BioNTech COVID vaccine

A review of side effects reported with coronavirus vaccines by the EMA’s safety committee has uncovered cases of inflammation of the heart in people receiving the Pfizer/BioNTech Comirnaty shot.  The Pharmacovigilance Risk Assessment Committee (PRAC) says it is aware of cases of myocarditis and pericarditis – inflammation of the heart muscle and membrane around the …

EMA panel probes heart inflammation with Pfizer/BioNTech COVID vaccine Read More »

Pharmaceutical firms’ shares tumble after US plans patent waiver on Covid vaccines

Shares in Chinese and US companies fell sharply following announcement to boost production Coronavirus – latest updates See all our coronavirus coverage Shares in pharmaceutical companies fell sharply after the US government threw its weight behind global plans for a patent waiver on Covid-19 vaccines to boost their production and distribution around the world. Shortly …

Pharmaceutical firms’ shares tumble after US plans patent waiver on Covid vaccines Read More »

Pfizer shares slump as support grows for COVID-19 vaccine patent waiver

Shares in COVID-19 vaccine manufacturers have taken a hit after the US signalled its support for waiving patents on them, a moved aimed to boost global supplies of the life-saving shots. Waiving the patent on proprietary knowledge would allow it to be shared with other manufacturers and the matter is being discussed by the World …

Pfizer shares slump as support grows for COVID-19 vaccine patent waiver Read More »

Pfizer says COVID-19 jab could rake in $26bn this year

Pfizer expects revenues from its BioNTech-partnered COVID-19 vaccine to reach an eye-watering $26 billion this year, catapulting it to the top of the world’s biggest-selling medicines.  The company also said that it doesn’t expect the massive sales to be a one-off, as demand from governments around the world for coronavirus vaccines will continue to be …

Pfizer says COVID-19 jab could rake in $26bn this year Read More »

Pfizer forecasts $26bn from annual sales of Covid-19 vaccine

Vaccine will generate 73% more than forecast based on contracts signed until mid-April Coronavirus – latest updates See all our coronavirus coverage US drugmaker Pfizer expects to make $26bn (£19bn) in revenues from sales of its Covid-19 vaccine this year, with its soaraway product accounting for more than a third of the company’s annual income. …

Pfizer forecasts $26bn from annual sales of Covid-19 vaccine Read More »

Alphamab and Pfizer Initiate P-II Trial Evaluating KN046 + Inlyta (axitinib) as a 1L Treatment of Non-Small Cell Lung Cancer

Shots: The P-II trial will evaluate the efficacy, safety, and tolerability of KN046 + Pfizer’s Inlyta (axitinib) as a 1L treatment of NSCLC. The 1EPs of the study are ORR The P-II trial of KN046 for advanced NSCLC has demonstrated superior tolerability, safety, as well as PFS and OS. Following the results, the companies have …

Alphamab and Pfizer Initiate P-II Trial Evaluating KN046 + Inlyta (axitinib) as a 1L Treatment of Non-Small Cell Lung Cancer Read More »

India wants access to cheap copies of Covid vaccines. So why is Australia holding out?

More than 100 countries are pushing for a temporary waiver of IP rules to boost vaccine access for developing nations. Why hasn’t it been approved? As India grapples with a devastating Covid wave that has overwhelmed its hospitals, offers of aid, including from Australia, have flooded in from around the world. The help on offer …

India wants access to cheap copies of Covid vaccines. So why is Australia holding out? Read More »

UK orders 60m ‘booster’ doses of Pfizer/BioNTech COVID vaccine

The UK has ordered an extra 60 million doses of the Pfizer/BioNTech COVID-19 vaccine, which could be used as a potential booster campaign in the autumn. Health secretary Matt Hancock made the announcement in a press briefing, revealing that officials think they may have to boost protection for the population during the winter. The UK …

UK orders 60m ‘booster’ doses of Pfizer/BioNTech COVID vaccine Read More »

UK orders 60m more doses of Pfizer Covid vaccine for booster jabs

Health secretary says greater supplies of vaccine will help safeguard progress in tackling coronavirus Coronavirus – latest updates See all our coronavirus coverage The UK has ordered a further 60m doses of the Pfizer/BioNTech Covid vaccine in an effort to ensure that booster jabs can be given from this autumn, the government has announced. The …

UK orders 60m more doses of Pfizer Covid vaccine for booster jabs Read More »

ViewPoints Interview: Pyxis Oncology’s Dr. Lara S. Sullivan and Dr. Ronald Herbst Share Insights on the Importance of Series B Funding to Advance their Portfolio

In an interview with PharmaShots, Dr. Lara S. Sullivan, Chief Executive Officer, and Dr. Ronald Herbst, Chief Scientific Officer of Pyxis Oncology share insight on the importance of Series B funding and shed light on the company’s strategy and near-term goals. Shots: Pyxis Oncology reported that it raised $152M in a series B on the …

ViewPoints Interview: Pyxis Oncology’s Dr. Lara S. Sullivan and Dr. Ronald Herbst Share Insights on the Importance of Series B Funding to Advance their Portfolio Read More »

What Covid vaccines does the UK have and which are in the works?

As Valneva recruits volunteers for final stage trials of its vaccine, here is the current state of play in Britain Coronavirus – latest updates See all our coronavirus coverage Vaccines to protect against the coronavirus were designed, tested and manufactured in record time, and several have been approved for use in the UK vaccination programme, …

What Covid vaccines does the UK have and which are in the works? Read More »

PharmaShots’ Key Highlights of First Quarter 2021

The first quarter of 2021 highlights new approvals, M&A, and the clinical data of COVID-19 vaccines. The companies expand their working in COVID-19 by targeting South African & Brazil variants along with other emerging variants Starting with the latest acquisition, Amgen acquired Five Prime for $1.9B, Jazz acquired JW while Boston acquired Preventice. This quarter …

PharmaShots’ Key Highlights of First Quarter 2021 Read More »

UK Vaccine Taskforce head lifts lid on Novavax deal

The UK’s unique offering as a life sciences research hub helped convince US biotech Novavax to develop its COVID-19 jab there, according to the head of the country’s Vaccines Taskforce.  Last August the UK government finalised a deal with Novavax to purchase 60 million doses of the NVX-CoV2373 vaccine, which will also be manufactured in …

UK Vaccine Taskforce head lifts lid on Novavax deal Read More »

EU orders another 100m doses of Pfizer/BioNTech COVID jab

The EU has continued a refocus of its COVID-19 vaccination drive on mRNA shots, ordering another 100 million doses of Pfizer and BioNTech’s Comirnaty shot.  The new deal takes the total number of Comirnaty shots ordered by the EU for delivery this year to 600 million, and comes amid an ongoing debate about the safety …

EU orders another 100m doses of Pfizer/BioNTech COVID jab Read More »

Risk of brain clots higher with COVID than vaccine, study suggests

A study has suggested that the risk of getting a serious brain clot is eight to 10 times higher in people with COVID-19 than those who get a vaccine. There are some big caveats with the research from Oxford University – it was based on data from people in the US who had received either …

Risk of brain clots higher with COVID than vaccine, study suggests Read More »

Covid booster shot warning ‘underlines urgent need for Australia to make mRNA vaccines’

Pfizer boss flags likelihood that extra jabs will be required – raising prospect of increased global demand Covid booster shot could be needed after nine to 12 months, White House says Experts say suggestions that a third dose of Pfizer may be needed within 12 months again show why Australia “urgently” needs to develop an …

Covid booster shot warning ‘underlines urgent need for Australia to make mRNA vaccines’ Read More »

Will Covid vaccines protect us against new variants? | Julian Tang

New strains such as the South African variant that’s emerged in south London will require constant vigilance as lockdown eases All viruses mutate. They do this to adapt and survive better in their specific host. The virus that causes Covid-19 is no different: it has moved from the animal realm, where it most likely originated …

Will Covid vaccines protect us against new variants? | Julian Tang Read More »

Pfizer/Myovant take relugolix contraceptive combination pill into phase 3

Pfizer and Myovant have begun a late-stage trial of their potential uterine fibroid drug relugolix, as part of a contraceptive combination tablet.  The FDA is already reviewing data from two phase 3 trials of relugolix as a treatment for fibroids, with a decision due on or before 1 June. Pfizer and Myovant began a collaboration …

Pfizer/Myovant take relugolix contraceptive combination pill into phase 3 Read More »

AZ aims at Pfizer, GSK with potential new PARP cancer drug

AstraZeneca’s Lynparza (olaparib) blazed a trail for the new class of PARP drugs when it was approved in 2014 to treat ovarian cancer.  The drug has gone on to become a huge success, generating sales of nearly $1.8 billion in 2020 alone as part of a partnership with Merck & Co after expanded use in …

AZ aims at Pfizer, GSK with potential new PARP cancer drug Read More »

South African variant may evade Pfizer/BioNTech vaccine, study finds

The coronavirus variant discovered in South Africa may evade Pfizer/BioNTech’s vaccine, according to a real-world data study conducted in Israel. Known as variant B.1.351, the variant was found to make up around 1% of all COVID-19 cases across the people studied according to results which have yet to be peer-reviewed. But among patients who had …

South African variant may evade Pfizer/BioNTech vaccine, study finds Read More »

What does Australia’s new advice on the AstraZeneca Covid vaccine mean and what is the risk?

Experts say the development of blood clots after getting the jab is still an ‘exceedingly rare’ side effect. So what triggered the government’s change in position? Australia’s vaccine rollout is facing a major shake-up after the federal government heeded the advice of its independent health expert advisory body to avoid giving the AstraZeneca vaccine to …

What does Australia’s new advice on the AstraZeneca Covid vaccine mean and what is the risk? Read More »

Top 20 BioPharma Companies based on 2020 Total Revenue

Despite having the global pandemic, the biopharma companies were involved in multiple M&A, licensing deals. The major focus of the year remains the production and distribution of vaccines to combat the COVID-19 globally All the companies on our list are on the front line to combat this global crisis. The top 20 companies on the …

Top 20 BioPharma Companies based on 2020 Total Revenue Read More »

Two new vaccines on the way – with more to follow this year

Half of UK adults have had a first jab, and future supplies of millions of doses look assured Coronavirus – latest updates See all our coronavirus coverage Two very different jabs have been responsible for inoculating Britain’s strikingly high number of vaccine recipients – with more than half of the country’s adult population having now …

Two new vaccines on the way – with more to follow this year Read More »

PharmaShots Weekly Snapshots (Mar 29 – Apr 02, 2021)

Pfizer and BioNTech Report Results of BNT162b2 to Prevent COVID-19 Published: Apr 2, 2021 | Tags: Pfizer and BioNTech, Report, Results, BNT162b2, Prevent, COVID-19 Acceleron Presents Results of Sotatercept in P-II PULSAR Trial for the Treatment of Pulmonary Arterial Hypertension, Published in NEJM Published: Apr 2, 2021 | Tags: Acceleron, Presents, Results, Sotatercept, P-II PULSAR …

PharmaShots Weekly Snapshots (Mar 29 – Apr 02, 2021) Read More »

Pfizer vaccine has 91% efficacy for up to six months, trial shows

Findings based on two doses three weeks apart are first to show shot remains effective for many months Coronavirus – latest updates See all our coronavirus coverage The coronavirus vaccine developed by Pfizer and its German partner BioNTech protects against symptomatic Covid for up to six months, an updated analysis of clinical trial data has …

Pfizer vaccine has 91% efficacy for up to six months, trial shows Read More »

Insights+ Key Biosimilars Events of March 2021

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of March, Samsung Bioepis Initiated P-I Study of SB17 …

Insights+ Key Biosimilars Events of March 2021 Read More »

Pfizer & BioNTech report Covid-19 vaccine shows 100% efficacy in kids 12 to 15

Based on the efficacy and safety data for their Covid-19 vaccine in younger teens, Pfizer and BioNTech plan to ask regulators to expand emergency authorization to include this younger group. The expansion could make the mRNA vaccine available to this age group in time for the coming school year.

Pfizer finds Covid vaccine safe and effective for children 12 to 15

Drug firm in partnership with BioNTech to seek US approval after trials found vaccine ‘well-tolerated’ in school-age children Pfizer plans to seek emergency approval for its Covid vaccine in younger people after a US trial found the jab prevented the disease and was “well-tolerated” in 12- to 15-year-olds. Related: Germany restricts use of AstraZeneca jab …

Pfizer finds Covid vaccine safe and effective for children 12 to 15 Read More »

How the AstraZeneca vaccine became a political football – and a PR disaster

Newly accused of data manipulation by the US, AstraZeneca has faced unprecedented scrutiny over the past six months Coronavirus – latest updates See all our coronavirus coverage It was billed as the vaccine to deliver the world from Covid. But over the last six months, AstraZeneca – whose jab was designed to save thousands of …

How the AstraZeneca vaccine became a political football – and a PR disaster Read More »

Thumbs-down from FDA experts for Pfizer/Lilly’s painkiller tanezumab

After more than a decade of fraught clinical development it looks like the end of the line for Pfizer/Lilly painkiller tanezumab, which promised to be an alternative to addictive opioid painkillers. Pfizer has asked the FDA for a licence for tanezumab in moderate to severe osteoarthritis pain, where other painkillers aren’t working or are inappropriate. …

Thumbs-down from FDA experts for Pfizer/Lilly’s painkiller tanezumab Read More »

Pfizer begins clinical trials of COVID-19 antiviral pill

Pfizer has begun clinical development of an antiviral pill against COVID-19, which could be prescribed to patients at the first sign of infection. The company was the first to get a vaccine approved against the disease with BioNTech and is now aiming to make a pill that could prevent it escalating once patients are infected. …

Pfizer begins clinical trials of COVID-19 antiviral pill Read More »

FDA worried about Pfizer/Lilly pain drug safety ahead of key meeting

After a long and troubled development the fate of Pfizer/Lilly’s tanezumab painkiller injection is in the balance ahead of a key meeting of advisers later this week.  Safety has been an issue throughout development and in 2012 the FDA put tanezumab on clinical hold because of a class-related issue with joint destruction, which was finally …

FDA worried about Pfizer/Lilly pain drug safety ahead of key meeting Read More »

The Guardian view on pandemic politics: we need cooperation, not confrontation | Editorial

Vaccinating the world is the only way out of Covid, but a mixture of nationalism and protectionism is blocking the exit Covid-19 has proved to be the greatest humanitarian and economic disaster of the century. A reported 2.7 million people have already died from the pathogen. Its recession is estimated to be twice as deep …

The Guardian view on pandemic politics: we need cooperation, not confrontation | Editorial Read More »

PharmaShots Weekly Snapshots (Mar 15 – 19, 2021)

Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Published: Mar 19, 2021 | Tags: Takeda, Collaborates, Anima, Discover, Develop, mRNA Translation Modulators, Neurological Diseases Kiniksa’s Arcalyst (rilonacept) Receives the US FDA’s Approval for the Treatment of Pericarditis Published: Mar 19, 2021 | Tags: Kiniksa, Arcalyst (rilonacept), Receives, US, FDA, …

PharmaShots Weekly Snapshots (Mar 15 – 19, 2021) Read More »

PharmaShots Weekly Snapshots (Mar 15 – 19, 2021)

Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Published: Mar 19, 2021 | Tags: Takeda, Collaborates, Anima, Discover, Develop, mRNA Translation Modulators, Neurological Diseases Kiniksa’s Arcalyst (rilonacept) Receives the US FDA’s Approval for the Treatment of Pericarditis Published: Mar 19, 2021 | Tags: Kiniksa, Arcalyst (rilonacept), Receives, US, FDA, …

PharmaShots Weekly Snapshots (Mar 15 – 19, 2021) Read More »

Pfizer Signs a WW License Agreement with Pyxis to Develop and Commercialize Two ADC Candidates

Shots: Pfizer to receive an up front, equity in Pyxis and is eligible for development & commercial milestones as well as royalties on potential sales of ADCs Pyxis gets a WW license to develop and commercialize PYX-201 and PYX-203. Pfizer will continue to support the development and advancement of ADCs portfolio via an equity investment …

Pfizer Signs a WW License Agreement with Pyxis to Develop and Commercialize Two ADC Candidates Read More »

Pfizer Signs a WW License Agreement with Pyxis to Develop and Commercialize Two ADC Candidates

Shots: Pfizer to receive an up front, equity in Pyxis and is eligible for development & commercial milestones as well as royalties on potential sales of ADCs Pyxis gets a WW license to develop and commercialize PYX-201 and PYX-203. Pfizer will continue to support the development and advancement of ADCs portfolio via an equity investment …

Pfizer Signs a WW License Agreement with Pyxis to Develop and Commercialize Two ADC Candidates Read More »

3 Ways Providers Can Navigate COVID-19 Vaccination Rollout Successfully

Lisa Romano, MSN, RN, Chief Nursing Officer at CipherHealth The New Year brings hope and promises that an end to the COVID-19 pandemic is in sight. With two vaccines authorized by the FDA for emergency use, and close to 3 million healthcare workers already vaccinated, there is hope that this virus will be eradicated and …

3 Ways Providers Can Navigate COVID-19 Vaccination Rollout Successfully Read More »

Regulators questioned integrity of Pfizer/BioNTech vaccine, leaked files show

European regulators questioned the integrity of early batches of Pfizer/BioNTech’s mRNA vaccine, although the matter was resolved before approval, according to information leaked online following a cyberattack. As it conducted its analysis of the vaccine in December, the European Medicines Agency’s systems were targeted by unknown hackers. Following this, more than 40 megabytes of classified …

Regulators questioned integrity of Pfizer/BioNTech vaccine, leaked files show Read More »

Harris Poll Finds Large Boost in Pharma Industry Reputation

As the COVID-19 vaccine roll-out gains in intensity, it has become common to hear people toss out the names of pharmaceutical companies like Pfizer, Moderna and AstraZeneca with the same ease that they refer to their favorite brands of ketchup or peanut butter. This isn’t typical. While direct-to-consumer advertising has perhaps increased some awareness of …

Harris Poll Finds Large Boost in Pharma Industry Reputation Read More »

EU probes low platelet safety issue with COVID-19 shots

EU regulators are reviewing reports of low blood platelets in patients who received any of the three approved COVID-19 vaccines from Pfizer/BioNTech, AstraZeneca and Moderna. The experts have also recommended a safety update on the label of Oxford University/AstraZeneca’s COVID-19 vaccine, which has been linked to anaphylactic reactions, in what has turned out to be …

EU probes low platelet safety issue with COVID-19 shots Read More »

Sanofi/Translate start clinical trial of mRNA COVID shot

Sanofi and Translate BIO have begun a clinical trial of their potential mRNA COVID-19 shot, as the French pharma struggles to keep pace with rivals despite its background in vaccines. While Pfizer/BioNTech and Moderna have been able to produce mRNA vaccines in a matter of months Sanofi is considerably behind with its collaboration with Translate …

Sanofi/Translate start clinical trial of mRNA COVID shot Read More »

Israeli real-world data on Pfizer vaccine shows high Covid protection

Jab has 97% efficacy against disease and death and 94% against infection without symptoms The Pfizer/BioNTech vaccine appears to give high protection against asymptomatic Covid-19, according to data from Israel – a finding that will boost hopes that mass vaccination can stop the spread of the virus. The top line of the real-world results, issued …

Israeli real-world data on Pfizer vaccine shows high Covid protection Read More »

Insights+: Breakthrough Therapy Designation by the US FDA in 2020

Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The Breakthrough Designation is granted to the drug candidates as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available …

Insights+: Breakthrough Therapy Designation by the US FDA in 2020 Read More »

J&J manufacturing delays hit US vaccine rollout

The rollout of the US COVID-19 vaccination programme slowed up this week because manufacturing delays mean no new doses of the recently approved Johnson & Johnson vaccine are available. The White House said on Tuesday that the government will distribute around 18.5 million doses of COVID-19 vaccines this week, fewer than last week because of …

J&J manufacturing delays hit US vaccine rollout Read More »

Pfizer/BioNTech COVID jab works against Brazil variant; lab study

A laboratory study suggests Pfizer and BioNTech’s COVID-19 vaccine Comirnaty could be effective against a Brazilian variant of the SARS-CoV-2 virus – known as P.1 – that is worrying health officials around the world.  The study suggests that serum taken from patients injected with the mRNA shot, also known as BNT162b2, was able to neutralise …

Pfizer/BioNTech COVID jab works against Brazil variant; lab study Read More »

BioNTech co-founder says gender equality made vaccine possible

Özlem Türeci credits firm’s more than 50% female workforce for speed at which first viable jab created The co-founder and chief medical officer of BioNTech has credited its speed at producing a viable vaccine to the fact its workforce is more than 50% female. Speaking on International Women’s Day, Özlem Türeci also said the fact …

BioNTech co-founder says gender equality made vaccine possible Read More »

From Pfizer to Moderna: who’s making billions from Covid vaccines?

The companies in line for the biggest gains – and the shareholders who have already made fortunes Coronavirus – latest updates See all our coronavirus coverage The arrival of Covid-19 vaccines promises a return to more normal life – and has created a global market worth tens of billions of dollars in annual sales for …

From Pfizer to Moderna: who’s making billions from Covid vaccines? Read More »

PharmaShots Weekly Snapshots (Mar 01 – 05, 2021)

Eli Lilly and Incyte Report Results of Olumiant (baricitinib) in P-III BRAVE-AA2 Study for Severe Alopecia Areata Published: Mar 5, 2021 | Tags: Eli Lilly and Incyte, Report, Results, Olumiant (baricitinib), P-III, BRAVE-AA2, Study, Severe, Alopecia Areata Takeda Reports NDA Submission to Import and Distribute Moderna’s mRNA-1273 in Japan Published: Mar 5, 2021 | Tags: …

PharmaShots Weekly Snapshots (Mar 01 – 05, 2021) Read More »

Pfizer’s Lorbrena (lorlatinib) Receives FDA’s Approval for Expanding its Indication to Treat ALK-Positive Metastatic Lung Cancer

Shots: The approval is based on P-III CROWN study assessing Lorbrena vs Xalkori (crizotinib) monthx in 296 people in a ratio (1:1) with prior untreated advanced ALK-positive NSCLC The P-III study resulted in a 72% reduction in risk of progression or death as assessed by BICR. The prespecified exploratory analysis showed IC-ORR was (82% vs …

Pfizer’s Lorbrena (lorlatinib) Receives FDA’s Approval for Expanding its Indication to Treat ALK-Positive Metastatic Lung Cancer Read More »

First Databank Clinician Addresses COVID-19 Vaccine Skepticism – Q/A

Joan Kapusnik-Uner PharmD, FCSHP, FASHP, VP of Clinical Content for First Databank (FDB) As the Biden administration ramps up its efforts to increase the access of COVID-19 vaccines to more Americans, there are a large number of Americans who are skeptical about of the COVID-19 vaccine. About 1 in 3 Americans stated they definitely or probably …

First Databank Clinician Addresses COVID-19 Vaccine Skepticism – Q/A Read More »

Data back use of AZ and Pfizer COVID-19 vaccines in older people

Both the Pfizer/BioNTech and Oxford University/AstraZeneca COVID-19 vaccines are highly effective in reducing COVID-19 infections among older people, according to an emerging study data. Data came from Public Health England, which has submitted findings of a real-world study for peer review. The article compares the rate of vaccination in symptomatic people aged over 70 years …

Data back use of AZ and Pfizer COVID-19 vaccines in older people Read More »

Pfizer vaccine may be less effective in people with obesity, says study

Healthcare workers with obesity found to produce only about half the antibodies healthy people do Coronavirus – latest updates See all our coronavirus coverage The Pfizer/BioNTech vaccine may be less effective in people with obesity, data suggests. Italian researchers have discovered that healthcare workers with obesity produced only about half the amount of antibodies in …

Pfizer vaccine may be less effective in people with obesity, says study Read More »

PharmaShots Weekly Snapshots (Feb 22- 26, 2021)

Regeneron Reports IDMC Clearance of Efficacy for REGEN-COV (Casirivimab + Imdevimab) in P-III COVID-19 Outpatient Outcomes Trial Published: Feb 26, 2021 | Tags: Regeneron, Reports, IDMC, Clearance, Efficacy, REGEN-COV (Casirivimab + Imdevimab), P-III, COVID-19, Outpatient, Outcomes, Trial Daiichi Sankyo Collaborates with LYSA-LYSARC-CALYM for Valemetostat in Patients with R/R B-Cell Lymphoma Published: Feb 26, 2021 | …

PharmaShots Weekly Snapshots (Feb 22- 26, 2021) Read More »

Australia considers approving Pfizer Covid vaccine for standard cold storage

Therapeutic Goods Administration may follow US in allowing vaccines to be stored at warmer temperatures Pfizer’s Covid-19 vaccine could soon be delivered at temperatures 50 degrees warmer than currently required if Australia follows the US’s lead to ease the rollout. The potential change in storage temperature requirements is being considered as the federal health department …

Australia considers approving Pfizer Covid vaccine for standard cold storage Read More »

Pfizer files tick-borne encephalitis shot with FDA

Pfizer may have been making headlines with the COVID vaccine it developed with BioNTech, but it’s not the only infectious disease the big pharma is targeting. In a statement, Pfizer said the FDA has granted a fast review for TicoVac tick-borne encephalitis (TBE) vaccine, to prevent the disease in individuals one year of age or …

Pfizer files tick-borne encephalitis shot with FDA Read More »

Pfizer Reports the US FDA’s Acceptance and Priority Review of BLA for Ticovac (Tick-Borne Encephalitis Vaccine)

Shots: The US FDA has accepted the PR of BLA for TicoVac to prevent TBE in patients aged ≥1year with an anticipated PDUFA date in Aug 2021. If approved, the vaccine may help reduce the risk of TBE for people traveling to endemic areas The BLA is based on clinical trials that assess TicoVac across …

Pfizer Reports the US FDA’s Acceptance and Priority Review of BLA for Ticovac (Tick-Borne Encephalitis Vaccine) Read More »

Number of UK Covid vaccinations falls by a third as vaccine supply dips

Factors at play include high uptake plus stockpiling for second doses, but Matt Hancock promises ‘bumper weeks in March’ Coronavirus – latest updates See all our coronavirus coverage The number of Covid vaccines administered in the UK has fallen by over a third in the last week as ministers warned of a short-term dip in …

Number of UK Covid vaccinations falls by a third as vaccine supply dips Read More »

PharmaShots Weekly Snapshots (Feb 15- 19, 2021)

RedHill Signs a Manufacturing Agreement with Cosmo for Movantik and RHB-204  Published: Feb 19, 2021 | Tags: RedHill, Signs, Manufacturing, Agreement, Cosmo, Movantik, RHB-204 Astellas and Seagen Reports Submission of Two BLA to the US FDA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer Published: Feb 19, 2021 | Tags: Astellas, Seagen, Reports, Submission, …

PharmaShots Weekly Snapshots (Feb 15- 19, 2021) Read More »

Scientists make case for one dose of Pfizer’s COVID jab to stretch supplies

Two researchers have suggested that the second dose of Pfizer and BioNTech’s COVID-19 vaccine could be delayed, as this would increase the number of people that can be protected while supplies are limited without compromising its efficacy.  The two Canadian researchers – Danuta Skowronski and Gaston De Serres – make the suggestion in a letter …

Scientists make case for one dose of Pfizer’s COVID jab to stretch supplies Read More »

Three strategies for managing loss of exclusivity successfully

“Patent losses could sink Allergan”.1 “Drug prices to plummet in wave of expiring patents”.2 “Price decay after loss of brand exclusivity”.3 These are just three headlines that come up when you Google “drug patent expiry”.4 It’s no wonder “loss of exclusivity (LOE)” or “the patent cliff” is an ominous prospect for drug manufacturers – shrouded …

Three strategies for managing loss of exclusivity successfully Read More »

South African variant may cut response from Pfizer/BioNTech shot, study finds

The South African coronavirus variant may cut the effectiveness of Pfizer/BioNTech’s vaccine by around two thirds, according to a laboratory study. Researchers from the University of Texas Medical Branch based their findings on lab tests using SARS-CoV-2 coronaviruses that were genetically engineered to have the same mutations as those in the strain that is causing …

South African variant may cut response from Pfizer/BioNTech shot, study finds Read More »

Europe orders another 200m doses of Pfizer/BioNTech COVID shot

The European Commission has ordered another 200 million doses of the Pfizer/BioNTech COVID-19 vaccine Comirnaty, bringing the bloc’s total order to 500 million doses. Under the latest deal the commission has an option for a further 100 million doses to be supplied to the 27 European member states. This new agreement is in addition to …

Europe orders another 200m doses of Pfizer/BioNTech COVID shot Read More »

North Korea ‘launched cyber-attack on Pfizer for COVID-19 jab data’

A news agency is claiming that North Korea launched a cyber-attack on Pfizer in a bid to steal information about its BioNTech-partnered COVID-19 vaccine, citing South Korea’s National Intelligence Service (NIS). The Yonhap agency said the revelation was made during a closed-door meeting of the intelligence committee of South Korea’s National Assembly. According to recent …

North Korea ‘launched cyber-attack on Pfizer for COVID-19 jab data’ Read More »

Merck gets a leg-up for Keytruda in first-line kidney cancer

New phase 3 data have shored up the position of Merck & Co’s cancer immunotherapy Keytruda in the increasingly competitive first-line kidney cancer market.  The data from the KEYNOTE-581/CLEAR study reveal that the combination of PD-1 inhibitor Keytruda (pembrolizumab) with Eisai’s targeted tyrosine kinase inhibitor Lenvima (lenvatinib) reduced the risk of disease progression of death …

Merck gets a leg-up for Keytruda in first-line kidney cancer Read More »

Pfizer’s Panzyga Receives the US FDA’s Approval of sBLA for Chronic Inflammatory Demyelinating Polyneuropathy

Shots: The approval is based on the P-III study that involves assessing Panzyga (IVIg) in 142 patients with CIDP. The study evaluated more than one maintenance dosing option while the efficacy, safety, and tolerability were observed during 7 maintenance infusions @3wks. intervals over a 6mos. period The study met 1EPs i.e. 80% of patients achieved …

Pfizer’s Panzyga Receives the US FDA’s Approval of sBLA for Chronic Inflammatory Demyelinating Polyneuropathy Read More »

Top 20 Biopharma Deal Terminations of 2020 Based on Total Deal Value

The biopharma industry saw numerous deal terminations in 2020. Clinical and regulatory results, change in control limitations, and strategic reprioritizations were among the most common reasons for deal termination. Sanofi and Hanmi’s agreement in 2015 ranked first under which Hanmi regained WW rights to its protein/peptide discovery technology, lapscovery. The second position goes to the …

Top 20 Biopharma Deal Terminations of 2020 Based on Total Deal Value Read More »

EU finalises order for 300 million more Pfizer/BioNTech COVID-19 shots

The European Union has rubber-stamped its order for a further 300 million doses of Pfizer/BioNTech’s COVID-19 vaccine, according to press reports. Citing a European Commission spokesperson, Reuters reported the EU had finalised a preliminary contract for 300 million doses that was first announced a month ago. This is on top of the 300 million doses …

EU finalises order for 300 million more Pfizer/BioNTech COVID-19 shots Read More »

PharmaShots Weekly Snapshot (Feb 01-05, 2021)

Reistone Report Results for SHR0302 in P-II Study to Treat Ulcerative Colitis Published: Feb 5, 2020 | Tags: Reiston, Report, Result, SHR0302, P-II, Study, Treat, Ulcerative Colitis Enzene Receives Marketing Authorization for Teriparatide (biosimilar) in India Published: Feb 5, 2020 | Tags: Enzene, Receives, Marketing Authorization, Teriparatide (biosimilar), India Johnson & Johnson Reports EUA Submission …

PharmaShots Weekly Snapshot (Feb 01-05, 2021) Read More »

FDA holds back from action over Xeljanz safety study

The FDA has said it will wait for additional results from last week’s trial showing an increased risk of cardiac side effects with Pfizer’s arthritis blockbuster Xeljanz before deciding on further action. The post-marketing ORAL Surveillance safety study showed that JAK inhibitor Xeljanz (tofacitinib) was associated with a higher rate of heart attacks and cancer …

FDA holds back from action over Xeljanz safety study Read More »

Pfizer Signs a License and Research Agreement with Imcyse to Develop Imotopes for Rheumatoid Arthritis

Shots: Imcyse to receive up front, ~$180M as milestones along with royalties. Pfizer to purchase an equity stake in Imcyse Initially, the companies will collaborate to develop existing lead candidates and further optimize potential molecules. Later, Pfizer will lead clinical development and commercialization activities for the program The Imotope platform is a curative approach to …

Pfizer Signs a License and Research Agreement with Imcyse to Develop Imotopes for Rheumatoid Arthritis Read More »

One Pfizer/BioNTech jab gives ‘90% immunity’ from Covid after 21 days

New analysis runs counter to earlier study which suggested one dose may not give adequate protection Coronavirus – latest updates See all our coronavirus coverage One dose of the Pfizer/BioNTech vaccine gives people about 90% protection from Covid by 21 days, according to an analysis of Israel’s mass vaccination programme. The data analysis, carried out …

One Pfizer/BioNTech jab gives ‘90% immunity’ from Covid after 21 days Read More »

PharmaShots Weekly Snapshots (Jan 25- 29, 2021)

Roche Collaborate with Cambridge Quantum Computing to Develop Quantum Algorithm for Drug Discovery and Development Published: Jan 29, 2020 | Tags: Roche, Collaborate, Cambridge Quantum Computing, Develop, Quantum Algorithm, Drug, Discovery, Development Janssen Reports Results of Amivantamab in P-I CHRYSALIS Study for Metastatic or Unresectable NSCLC and EGFR Exon 20 Insertion Mutations Published: Jan 29, 2020 …

PharmaShots Weekly Snapshots (Jan 25- 29, 2021) Read More »

Bad news for Pfizer as blockbuster Xeljanz flunks safety study

JAK inhibitor Xeljanz is one of Pfizer’s top-selling drugs, despite a ‘black box’ warning for blood clots and cancers added to its label in 2019. Now, a study designed to prove its safety has achieved the opposite. The post-marketing safety study showed that Xeljanz (tofacitinib) – used to treat rheumatoid arthritis (RA) – was associated …

Bad news for Pfizer as blockbuster Xeljanz flunks safety study Read More »

Bad news for Pfizer as blockbuster Xeljanz flunks safety study

JAK inhibitor Xeljanz is one of Pfizer’s top-selling drugs, despite a ‘black box’ warning for blood clots and cancers added to its label in 2019. Now, a study designed to prove its safety has achieved the opposite. The post-marketing safety study showed that Xeljanz (tofacitinib) – used to treat rheumatoid arthritis (RA) – was associated …

Bad news for Pfizer as blockbuster Xeljanz flunks safety study Read More »

Novavax Covid vaccine shown to be nearly 90% effective in UK trial

UK vaccines taskforce has bought 60m doses after study found ‘spectacular results’ Coronavirus – latest updates See all our coronavirus coverage Another vaccine against Covid, trialled in the UK and bought by the government, has been shown to be nearly 90% effective and work against the UK and South African variants of the virus. The …

Novavax Covid vaccine shown to be nearly 90% effective in UK trial Read More »

Pfizer’s Xeljanz (tofacitinib) Fails to Meet its Co-Primary Endpoint in ORAL Surveillance Safety Study

Shots: The post marketing Oral Surveillance involves assessing the safety of tofacitinib at two doses (5 mg, bid and 10mg, bid) vs TNFi in 4362 patients in subjects with RA aged ≥ 50yrs. and had at least one additional CV risk factor The primary analyses include 135 subjects with MACE and 164 subjects with malignancies. …

Pfizer’s Xeljanz (tofacitinib) Fails to Meet its Co-Primary Endpoint in ORAL Surveillance Safety Study Read More »

Sanofi steps in to boost supplies of Pfizer/BioNTech’s COVID shot

Sanofi has said it is to begin manufacturing the COVID-19 shot from Pfizer and BioNTech in a week when supplies are in the spotlight. The French pharma will use its production infrastructure to boost supplies of the vaccine and perform late-stage manufacturing to supply over 125 million doses to the EU. In a statement Sanofi …

Sanofi steps in to boost supplies of Pfizer/BioNTech’s COVID shot Read More »

Head of AstraZeneca rejects calls for UK vaccine to be diverted to EU

Chief executive of pharmaceutical giant says the firm will honour UK’s earlier contract despite EU anger over shortfall Coronavirus – latest updates See all our coronavirus coverage AstraZeneca’s chief executive has insisted the UK will come first for vaccines as he rejected calls to divert doses to the European Union following a breakdown in supply. …

Head of AstraZeneca rejects calls for UK vaccine to be diverted to EU Read More »

EU means business over Covid vaccine exports, says Von der Leyen

Commission president says firms must deliver on orders after AstraZeneca warns of shortfall Coronavirus – latest updates See all our coronavirus coverage The EU “means business”, Ursula von der Leyen has said, as the bloc doubled down on plans for tighter monitoring of vaccine exports to countries outside of the union, such as the UK. …

EU means business over Covid vaccine exports, says Von der Leyen Read More »

Pharmaceutical giants not ready for next pandemic, report warns

Ten of the world’s most infectious diseases identified by the WHO not being catered for by drug firms The world’s biggest pharmaceutical firms are little prepared for the next pandemic despite a mounting response to the Covid-19 outbreak, an independent report has warned. Jayasree K Iyer, executive director of the Netherlands-based Access to Medicine Foundation, …

Pharmaceutical giants not ready for next pandemic, report warns Read More »

EU eyes tighter COVID-19 vaccine exports as access gets ugly

The EU has hit back at AstraZeneca’s plan to provide fewer doses of its COVID-19 vaccine than expected, saying it wants to see exactly where supplies have been delivered so far.   Moreover, it plans to rush through legislation requiring that all companies producing vaccines against COVID-19 in the EU have to notify the Commission …

EU eyes tighter COVID-19 vaccine exports as access gets ugly Read More »

Merck, Pfizer get EU nod for Bavencio as bladder cancer maintenance

Pfizer and partner Merck KGaA now have approval on both sides of the Atlantic for their checkpoint inhibitor Bavencio as a first-line maintenance therapy for bladder cancer, stealing a march on rival drugs in a highly competitive market. The European Commission has cleared Bavencio (avelumab) for locally advanced or metastatic urothelial carcinoma (UC) – the …

Merck, Pfizer get EU nod for Bavencio as bladder cancer maintenance Read More »

Aurinia’s Lupkynis for Lupus; FDA Fast Track Designation for Toripalimab; Wren Therapeutics’ Financing; Merck’s Covid-19 Vaccine Program End

Hot on the heels, Aurinia launches its drug in the Lupus market after GSK Aurinia Pharmaceuticals has recently got the USFDA approval for its Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active Lupus nephritis (LN). Lupkynis is the first oral therapy to receive FDA nod for Lupus …

Aurinia’s Lupkynis for Lupus; FDA Fast Track Designation for Toripalimab; Wren Therapeutics’ Financing; Merck’s Covid-19 Vaccine Program End Read More »

Vaccine experts call for clarity on UK’s 12-week Covid jab interval

British Society for Immunology calls for a robust programme monitoring the body’s immune response Experts have called for greater clarity on the monitoring in place to assess the 12-week dosing interval for Covid-19 vaccines, as the row over delayed second doses continues. The UK’s coronavirus vaccination programme was shifted late last year to prioritise administering …

Vaccine experts call for clarity on UK’s 12-week Covid jab interval Read More »

Vaccine experts call for clarity on UK’s 12-week Covid jab interval

British Society for Immunology calls for a robust programme monitoring the body’s immune response Experts have called for greater clarity on the monitoring in place to assess the 12-week dosing interval for Covid-19 vaccines, as the row over delayed second doses continues. The UK’s coronavirus vaccination programme was shifted late last year to prioritise administering …

Vaccine experts call for clarity on UK’s 12-week Covid jab interval Read More »

I’ve had my first vaccine jab. It gives me hope of liberation… but not yet

Exactly a year after his first story about coronavirus, our science editor received the Pfizer injection last week. Here he reflects on a remarkable scientific achievement Coronavirus – latest updates See all our coronavirus coverage I marked a grim anniversary in an unexpected manner last week. On 18 January last year, I wrote my first …

I’ve had my first vaccine jab. It gives me hope of liberation… but not yet Read More »

Vaccine experts defend UK decision to delay second Pfizer Covid jab

Medics told they risk undermining public confidence by querying policy of three-month gap between doses Coronavirus – latest updates See all our coronavirus coverage Leading vaccine experts have backed the government’s decision to delay the second dose for up to three months, after doctors warned that the strategy was proving “ever-more difficult to justify”. The …

Vaccine experts defend UK decision to delay second Pfizer Covid jab Read More »

World’s poor need action, not Covid ‘vaccine nationalism’, say experts

Nations outbidding each other creates an ‘immoral race towards the abyss’ Coronavirus – latest updates See all our coronavirus coverage Pharmaceutical companies should do more to transfer vaccine technology to prevent the poorest countries falling behind in the distribution of Covid-19 vaccines, according to an expert. The warning came from Dag-Inge Ulstein, the co-chair of …

World’s poor need action, not Covid ‘vaccine nationalism’, say experts Read More »

Leveraging Technology and Data for COVID-19 Vaccine Distribution

Kevin Grauman, President and CEO, QLess After months of uncertainty, hope is finally on the horizon as three viable COVID-19 vaccine candidates are moving closer towards approvals for public distribution. Getting to this stage was extremely labor-intensive, but unfortunately, it’s not the end of the hardships. The coronavirus vaccine will represent the largest vaccine distribution …

Leveraging Technology and Data for COVID-19 Vaccine Distribution Read More »

Top 20 Life Sciences Deals of 2020 by Total Deal Value

Life sciences companies are gearing up to enter new markets as they look to secure their positions after a spate of M&A, licensing, and research partnerships in 2020 Artios partnered with Merck with an option to license up to 8 oncology programs proving to be the highest valued deal of 2020 with a total deal …

Top 20 Life Sciences Deals of 2020 by Total Deal Value Read More »

Pfizer/BioNTech say COVID-19 vaccine works against UK variant

Laboratory studies have confirmed that antibodies stimulated by Pfizer and BioNTech’s COVID-19 vaccine can neutralise the new, more transmissible variant of SARS-CoV-2 identified in the UK. The results of the study – published online prior to peer review – are among the first data to indicate that any of the approved coronavirus vaccines can effectively …

Pfizer/BioNTech say COVID-19 vaccine works against UK variant Read More »

Single Covid vaccine dose in Israel ‘less effective than we hoped’

Surge in infections dampens optimism over country’s advanced immunisation programme Coronavirus – latest updates See all our coronavirus coverage Israel’s coronavirus tsar has warned that a single dose of the Pfizer/BioNtech vaccine may be providing less protection than originally hoped, as the country reported a record 10,000 new Covid infections on Monday. In remarks reported …

Single Covid vaccine dose in Israel ‘less effective than we hoped’ Read More »

COVID-19 vaccine supplies in spotlight as immunisation campaigns kick in

Supplies of COVID-19 vaccines are in the spotlight as countries across the world step up their immunisation campaigns against the pandemic. As vaccine manufacturers face unprecedented demand for their newly approved products, the race is on to provide enough shots for billions of people across the world. Pfizer and BioNTech have responded to this by …

COVID-19 vaccine supplies in spotlight as immunisation campaigns kick in Read More »

EU’s Covid vaccination debacle is down to institutional inflexibility

Supply delays underline there was no legal or economic justification for central planning A storm is raging over the EU’s failure to have ordered more of the approved Covid-19 vaccines ahead of time. Stéphane Bancel, the CEO of the US pharmaceutical company Moderna, which gained approval for its vaccine shortly after Pfizer/BioNTech, claims that the …

EU’s Covid vaccination debacle is down to institutional inflexibility Read More »

Allergic reactions prompt Moderna COVID vaccine pause in California

Public health authorities in California are seeking a halt on dosing of one lot of Moderna’s COVID-19 vaccine after reports of allergic reactions at one immunisation clinic. According to state epidemiologist Dr Erica Pan, there were a higher-than-expected number of suspected allergic reactions at a community clinic being used to administer the shot, with some …

Allergic reactions prompt Moderna COVID vaccine pause in California Read More »

Fauci backs Biden’s plan for 100 million COVID-19 shots

A promise by president-elect Joe Biden to carry out 100 million coronavirus vaccinations in his first 100 days in power is “absolutely doable”, according to the US leading infectious diseases expert Dr Anthony Fauci. Biden has announced ambitious initiatives to fight COVID-19 ahead of his inauguration, which is due to take place on Wednesday. While …

Fauci backs Biden’s plan for 100 million COVID-19 shots Read More »

UK to face short term delay in delivery of Pfizer vaccine

Overall number of doses delivered between January and March will remain the same, the firm says Coronavirus – latest updates See all our coronavirus coverage The UK is set to face short-term delays in delivery of the Pfizer/BioNTech coronavirus vaccine as the pharmaceutical company upgrades its production capacity. Pfizer is upscaling production at its plant …

UK to face short term delay in delivery of Pfizer vaccine Read More »

PharmaShots Weekly Snapshots (Jan 11 – 15, 2021)

Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria Published: Jan 15, 2020 | Tags: Novartis’, Ligelizumab (QGE031), Receives ,US FDA’s, Breakthrough Designation for Patients , Chronic Spontaneous Urticaria Philips Collaborates with Merck KGaA to Advance Personalized Fertility Treatment Published: Jan 15, 2020 | Tags: Philips, Collaborates, Merck KGaA, …

PharmaShots Weekly Snapshots (Jan 11 – 15, 2021) Read More »

J&J single-shot COVID-19 vaccine shows early promise

J&J has announced early trial results that suggest its single-shot coronavirus vaccine provides a sustained response against the virus ahead of a phase 3 trial readout due later this month. The UK has caused controversy in recent weeks by tinkering with the dosing regimens for coronavirus vaccines from AstraZeneca and Pfizer/BioNTech, which are being rolled …

J&J single-shot COVID-19 vaccine shows early promise Read More »

Pfizer’s Xalkori (crizotinib) Receives the US FDA’s Approval for ALK-Positive Anaplastic Large Cell Lymphoma In Children And Young Adult

Shots: The approval is based on the ADVL0912 study assessing Xalkori in 121 patients aged 1-21yrs. that included 26 patients with r/r, systemic ALK+ ALCL prior treated with at least one systemic treatment The study showed 88% ORR. Among 23 patients, who achieved a response, 39% maintained their response for at least 6mos. and 22% …

Pfizer’s Xalkori (crizotinib) Receives the US FDA’s Approval for ALK-Positive Anaplastic Large Cell Lymphoma In Children And Young Adult Read More »

PharmaShots’ Key Highlights of Fourth Quarter 2020

The fourth quarter of 2020 contains multiple initiations of clinical trials, big approvals, and numerous deals. COVID-19 related news remains at the peak in this quarter Multiple companies received regulatory bodies’ EUA for their vaccines and treatments for COVID-19. Initiating with, Regeneron sought the US FDA’s EUA for REGN-COV2 Ab combination while Health Canada accelerated …

PharmaShots’ Key Highlights of Fourth Quarter 2020 Read More »

Tivicay approved in Europe in new dispersible tablet for children with HIV

ViiV’s Tivicay is to become available in Europe in a new dispersible tablet form to treat children living with HIV. The joint venture, majority-owned by GlaxoSmithKline with Pfizer and Shionogi as shareholders, said the European Commission had granted a marketing authorisation for the new formulation. These tablets are used in combination with other antiretroviral agents …

Tivicay approved in Europe in new dispersible tablet for children with HIV Read More »

Hackers posted stolen COVID-19 vaccine info online, says EU regulator

Hackers posted stolen confidential information about Pfizer/BioNTech’s COVID-19 vaccine online, the European Medicines Agency has said in an update. The EMA last month revealed that documents relating to the Pfizer/BioNTech vaccine were stolen in a cyber-attack on its records. Since then the agency has been investigating the incident involving the theft of documents that formed …

Hackers posted stolen COVID-19 vaccine info online, says EU regulator Read More »

Netanyahu touts Pfizer deal after 20% of Israelis get Covid jab

Country will share data on its rapid vaccination campaign as ‘global model’, says PM Coronavirus – latest updates See all our coronavirus coverage One in five Israelis have been given first doses of coronavirus vaccines, roughly ten times higher than the UK and US, with the country aiming to have inoculated all eligible age groups …

Netanyahu touts Pfizer deal after 20% of Israelis get Covid jab Read More »

EU plans video summit after doubling supply of Pfizer Covid vaccine

Bloc agrees deal for a further 300m doses as hopes are raised for speedier rate of inoculations Coronavirus – latest updates See all our coronavirus coverage EU leaders are to hold a pandemic video summit on 21 January after the bloc said it had reached a deal with Pfizer and BioNTech for 300m more doses …

EU plans video summit after doubling supply of Pfizer Covid vaccine Read More »

PharmaShots Weekly Snapshot (Jan 4-8, 2020)

Almirall and Tyris Collaborate to Develop Next Generation Gene Therapies Published: Jan 7, 2020 | Tags: Almirall, Tyris, Collaborate, Develop, Next Generation, Gene Therapies Sarepta Reports Mixed Results of SRP-9001 (rAAVrh74.MHCK7.micro-dystrophin) in Part 1 of Study 102 for DMD    Published: Jan 7, 2020 | Tags: Sarepta, Reports, Mixed Results, SRP-9001, (rAAVrh74.MHCK7.micro-dystrophin), Part 1, Study 102, …

PharmaShots Weekly Snapshot (Jan 4-8, 2020) Read More »

Pfizer Reports the First Patients Dosing of PF-06939926 in P-III CIFFREO Study for DMD

Shots: The first patient has been dosed in P-III CIFFREO study assessing PF-06939926 vs PBO in 99 ambulatory male patients aged 4-7yrs. with DMD across 55 sites in 15 countries. The first patient was dosed at a site in Barcelona, Spain on Dec 29, 2020. The 1EPs of the study is the change in NSAA …

Pfizer Reports the First Patients Dosing of PF-06939926 in P-III CIFFREO Study for DMD Read More »

Pfizer/BioNTech vaccine may work against new virus mutation, scientists say

The Pfizer/BioNTech vaccine appears to work against an important mutation in the new coronavirus variants causing havoc in the UK and South Africa, according to research from the drugs giant. Findings of the lab study posted online have not yet been peer reviewed but provide some reassurance for countries like the UK, which are relying …

Pfizer/BioNTech vaccine may work against new virus mutation, scientists say Read More »

Resourceful or risky? The UK’s controversial COVID-19 vaccine strategy

As COVID-19 vaccines are hastily deployed in the UK for priority groups, a debate rages over the government’s controversial strategy to delay time between vaccine doses. When the UK announced the approval of the Pfizer-BioNTech and Oxford/AstraZeneca COVID-19 vaccines, it marked an exciting moment for the nation. After months of turbulent lockdown measures, the dawn …

Resourceful or risky? The UK’s controversial COVID-19 vaccine strategy Read More »

UK left trailing as EU quickly approves Moderna’s COVID-19 vaccine

The European Union has approved the coronavirus vaccine from Moderna, leaving the UK trailing because of changes to post-Brexit drug approval rules. With the UK reeling from one of the worst outbreaks of the disease, it’s a worrying situation for one of the countries worst hit by the pandemic that is relying on vaccines to …

UK left trailing as EU quickly approves Moderna’s COVID-19 vaccine Read More »

Pfizer Signs a License and Supply Agreement with ImaginAb for CD8 ImmunoPET Technology

Shots: ImaginAb to receive license fees and payments for manufacturing and other support and will supply clinical doses of 89Zr CD8 Immuno-PET agent to Pfizer for use in select oncology clinical trials ImaginAb will provide technical, clinical & regulatory support to Pfizer The collaboration follows the pre-competitive alliance b/w ImaginAb, Pfizer and other global companies …

Pfizer Signs a License and Supply Agreement with ImaginAb for CD8 ImmunoPET Technology Read More »

Pfizer deal paves way for approval of ImaginAb’s cancer imaging tech

ImaginAb has signed a deal with Pfizer, which it hopes will help it to gather information necessary for approval of its tumour imaging agent as a medical device in markets in the US and other countries. The California-based company has signed a non-exclusive license with Pfizer to supply its 89Zr CD8 Immuno-PET agent, which can …

Pfizer deal paves way for approval of ImaginAb’s cancer imaging tech Read More »

Pfizer Collaborates with Dewpoint to Develop Therapies for Rare Form of Muscular Dystrophy

Shots: Dewpoint to receive up front payment and up to $239M as research, development & commercial milestones along with royalties on sales of the therapies The companies collaborated for the development of therapies to treat DM1 The companies will collaborate their expertise to advance the novel therapeutic solutions addressing the patients’ needs Click here ­to­ read …

Pfizer Collaborates with Dewpoint to Develop Therapies for Rare Form of Muscular Dystrophy Read More »

Pfizer drops the blue pill, kicks off 2021 with new DNA logo

Pharma companies are always talking about moving ‘beyond the pill’, and Pfizer’s new brand identity embodies that – it’s decades old pill-like logo has been replaced with a DNA double helix that it says reflects its commitment to breakthrough science. The logo – which retains the company’s traditional blue colour scheme – has been more …

Pfizer drops the blue pill, kicks off 2021 with new DNA logo Read More »

No data to support UK delay of vaccines’ second dose, says WHO

Move to postpone second jab by up to 12 weeks is not supported by scientific evidence, experts find Coronavirus – latest updates See all our coronavirus coverage There is no scientific evidence for a delay of more than six weeks in administering the second dose of the Pfizer/BioNTech vaccine against Covid, say experts from the …

No data to support UK delay of vaccines’ second dose, says WHO Read More »

Pfizer/ OPKO Health’s Somatrogon; FDA EU for SCONE device; Antengene ATG-010 for rrMM and rrDLBCL; SanBio STEMTRA Phase 2 Interim Results

Pfizer and OPKO Health: A step closer to FDA Nod for pediatric growth hormone deficiency (GHD) drug, Somatrogon Pfizer and Opko had joined hands in 2014 to develop somatrogon, a pediatric growth hormone deficiency (GHD) drug. It comprises the natural sequence of growth hormone and a copy of the C-terminal peptide (CTP) from the beta …

Pfizer/ OPKO Health’s Somatrogon; FDA EU for SCONE device; Antengene ATG-010 for rrMM and rrDLBCL; SanBio STEMTRA Phase 2 Interim Results Read More »

Pfizer and OPKO Reports the US FDA’s Acceptance of BLA for Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency

Shots: The BLA submission is based on P-lll study assessing the safety and efficacy of Somatrogon (0.66 mg/kg, qw) vs Somatropin (0.034 mg/kg, qd) in 224 pediatric patients in the ratio of (1:1) with GHD The study met its 1EPs of non-inferiority as measured by annual height velocity @12mos.; least square mean (10.12 vs 9.78 …

Pfizer and OPKO Reports the US FDA’s Acceptance of BLA for Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency Read More »

Analysis: is it wise for England to mix and match Covid vaccines?

US experts warn against plan to give different second jab if supplies run low Coronavirus – latest updates See all our coronavirus coverage The UK is setting the pace around the world in the approval and use of Covid vaccines but, while other countries watch intently, not all are yet prepared to embrace what looks …

Analysis: is it wise for England to mix and match Covid vaccines? Read More »

Change in vaccine policy is a high-stakes gamble | Letters

The effectiveness of delaying the second dose of Covid vaccines must be carefully monitored, argues Dr Grizelda George, while Jan Mortimer and Jenny van Tinteren fear the move will increase distrust and uncertainty The manufacturer of the Pfizer/BioNTech vaccine has said its efficacy has only been assessed for two doses given three weeks apart. Therefore …

Change in vaccine policy is a high-stakes gamble | Letters Read More »

BioNTech criticises EU failure to order enough Covid vaccine

Firm races to fill potential gap left by bloc’s gamble on several vaccines being approved Coronavirus – latest updates See all our coronavirus coverage BioNtech has criticised the EU’s failure to order more doses of its coronavirus vaccine, saying it is now racing with its US partner Pfizer to boost production amid fears of a …

BioNTech criticises EU failure to order enough Covid vaccine Read More »

PharmaShots Weekly Snapshots (Dec 28- 31, 2020)

Sinopharm’s COVID-19 Vaccine Demonstrates 79% Efficacy in P-III Study Published: Dec 30, 2020 | Tags: COVID-19, Interim Analysis, New Coronavirus Inactivated Vaccine, P-lll Study, reports, results, Sinopharm Vertex Reports Health Canada’s Acceptance of Trikafta’s NDA for Priority Review to Treat Cystic Fibrosis Published: Dec 28, 2020 | Tags: CysticFibrosis, Drug, New, reports, Submission, Treatment, Trikafta, …

PharmaShots Weekly Snapshots (Dec 28- 31, 2020) Read More »

Questions hang over UK’s rollout of Oxford/AstraZeneca jab

Analysis: regulator surprises by approving 12-week gap between first and second shots of vaccine as well as Pfizer/BioNTech shot Coronavirus – latest updates See all our coronavirus coverage It’s a pragmatic solution to an incredibly urgent problem – how to immunise very large numbers of people at risk from a rampaging variant of Covid-19 in …

Questions hang over UK’s rollout of Oxford/AstraZeneca jab Read More »

AZ COVID-19 vaccine cleared in UK, dosing to start next week

The UK has approved AstraZeneca and Oxford University’s COVID-19 vaccine AZD1222 in another significant step forward in the fight against the pandemic, with first doses due to be administered on Monday. The UK government has already ordered 100 million doses of the adenovirus-based shot, enough to vaccinate 50 million people, adding to the 40 million …

AZ COVID-19 vaccine cleared in UK, dosing to start next week Read More »

‘I’ve never seen anything like it’: 2020 smashes records in global markets

From worst crash in a generation to record highs on news of a Covid vaccine, experts review the rollercoaster that was 2020 Coronavirus – latest updates See all our coronavirus coverage 2020 has been the most remarkable year for the global financial markets. After the Covid-19 pandemic triggered the worst crash in a generation, unprecedented …

‘I’ve never seen anything like it’: 2020 smashes records in global markets Read More »

Amazon, AstraZeneca, Pfizer, Merck to Build $10M Digital Health Innovation Lab in Israel

Rehovot Science Park What You Should Know: – Pfizer, AstraZeneca, Merck, and Teva, and Amazon Web Services (AWS) has been selected by the Israel Innovation Authority to establish an innovation lab in the fields of digital health and computational biology. – The innovation lab located in the Rehovot Science Park will receive a government budget …

Amazon, AstraZeneca, Pfizer, Merck to Build $10M Digital Health Innovation Lab in Israel Read More »

Pfizer Report the US FDA’s Acceptance and Priority Review of sNDA for Lorbrena (lorlatinib) to treat (ALK)-Positive (NSCLC)

Shots: The US FDA has accepted for Priority Review the sNDA is based on the pivotal CROWN study and is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) CROWN is P-lll, parallel 2-arm trial in which 296 previously untreated advanced ALK-positive NSCLC were randomized in ratio 1:1 to receive LORBRENA monotherapy (n=149) …

Pfizer Report the US FDA’s Acceptance and Priority Review of sNDA for Lorbrena (lorlatinib) to treat (ALK)-Positive (NSCLC) Read More »

Vulnerable should all get COVID-19 shot before summer, says NHS chief

NHS England’s chief executive Sir Simon Stevens has said that all vulnerable people over the age of 50 will be offered a COVID-19 vaccine by “late spring” in a message to healthcare workers. The prediction comes after the NHS announced on Christmas Eve that more than half a million people had received the Pfizer/BioNTech shot …

Vulnerable should all get COVID-19 shot before summer, says NHS chief Read More »

Myovant Signs Agreement with Pfizer to Develop and Commercialize Relugolix in Oncology and Women’s Health

Shots: Myovant & Pfizer will jointly develop & commercialize ORGOVYX (relugolix) in advanced prostate cancer & if approved, relugolix combination tablet in women’s health in the US & Canada. Myovant will receive ~$4.2B including $650M upfront, $200M in regulatory milestones for FDA approvals for relugolix combination tablet in women’s health, and tiered sales milestones upon …

Myovant Signs Agreement with Pfizer to Develop and Commercialize Relugolix in Oncology and Women’s Health Read More »

A USD 4.2 Billion Myovant/ Pfizer Deal; Audentes Therapeutics’ ASPIRO Trial Free to Proceed; First Generic of Drug for Severe Hypoglycemia Gets Approval; Teleflex Acquires Z-Medica

A USD 4.2 Billion Myovant/ Pfizer Deal Myovant Sciences have decided to put their forces and efforts together to advance the Prostate cancer market as they announced their partnership deal to develop and market relugolix for prostate cancer and women’s health.  Relugolix is a once-daily, oral gonadotropin-release hormone (GnRH) receptor antagonist. If approved, it will …

A USD 4.2 Billion Myovant/ Pfizer Deal; Audentes Therapeutics’ ASPIRO Trial Free to Proceed; First Generic of Drug for Severe Hypoglycemia Gets Approval; Teleflex Acquires Z-Medica Read More »

NHS doctors ‘scrabbling’ to get vaccine amid alarm at Covid variant

Many medics ‘frustrated’ about low priority given to frontline staff at high risk of infection Coronavirus – latest updates See all our coronavirus coverage Frontline NHS staff have been denied the Pfizer/BioNTech vaccine, leaving doctors alarmed and “scrabbling” to get immunised. A new survey reveals that almost two-thirds of medics who responded to it have …

NHS doctors ‘scrabbling’ to get vaccine amid alarm at Covid variant Read More »

PharmaShots Weekly Snapshots (Dec 21-23, 2020)

Roche’s Phesgo (Perjeta + Herceptin) Receives EC’s Approval for the Treatment of HER2-Positive Breast Cancer Published: Dec 23, 2020 | Tags: (Perjeta + Herceptin), EC’s Approval, HER2-positive Breast Cancer, Phesgo, receives, Roche, Treatment AMO Pharma Initiates P-II REACH-CDM study of AMO-02 (tideglusib) to treat Congenital Myotonic Dystrophy Published: Dec 22, 2020 | Tags: AMO Pharma, …

PharmaShots Weekly Snapshots (Dec 21-23, 2020) Read More »

AMA Adds 3 Additional CPT Codes for AstraZeneca’s COVID-19 Vaccine

What You Should Know: – The American Medical Association (AMA) announced the addition of three Current Procedural Terminology (CPT) codes for AstraZeneca’s COVID-19 vaccine. The American Medical Association (AMA) today announced that the Current Procedural Terminology (CPT®) code set is being updated by the CPT Editorial Panel to include immunization and administration codes that are unique to …

AMA Adds 3 Additional CPT Codes for AstraZeneca’s COVID-19 Vaccine Read More »

INVEST Precision Medicine Pitch Perfect winner spotlight: TrialSpark

Judges picked TrialSpark as the winner on the life sciences track of the pitch competition at MedCity’s virtual precision medicine conference. While the company is focused on improving clinical trials for others, it hopes eventually to bring drugs of its own to market.

Pfizer and BioNTech’s Comirnaty (BNT162b2) Receives EC’s Conditional Marketing Authorization for COVID-19

Shots: The approval is based on P-ll/lll study involve the assessment of Comirnaty (BNT162b2) vs PBO in 44,000 patients aged ≥16 yrs. in the ratio of (1:1) for COVID-19. The approval follows CHMP’s positive opinion to authorize the vaccine The P-III demonstrated 95% ER in participants without prior SARS-CoV-2 infection (first primary objective) and in …

Pfizer and BioNTech’s Comirnaty (BNT162b2) Receives EC’s Conditional Marketing Authorization for COVID-19 Read More »

‘Highly likely’ BioNTech vaccine will work against new strain, says CEO

BioNTech CEO Ugur Sahin has said that it is “highly likely” the company’s COVID-19 vaccine will work against the more infectious strain circulating in the south east of England, although further studies will be needed. Sahin was addressing a news conference after the vaccine was approved by the European Union, three weeks after the shot …

‘Highly likely’ BioNTech vaccine will work against new strain, says CEO Read More »

FDA gives nod to Moderna vaccine for Covid-19

The company’s vaccine is the second approved for emergency use by the FDA. It is expected to pose fewer logistical challenges than the first, which was developed by Pfizer and BioNTech.

Belgian minister tweets EU’s Covid vaccine price list to anger of manufacturers

Pharmaceutical companies complain of breach of confidentiality after amount EU has agreed to pay for leading vaccines goes public Coronavirus – latest updates See all our coronavirus coverage A Belgian minister has inadvertently blown the lid off a sensitive and commercial secret – the price that the EU has agreed to pay for the leading …

Belgian minister tweets EU’s Covid vaccine price list to anger of manufacturers Read More »

FDA aims for fast approval of Moderna’s COVID-19 shot after panel vote

The FDA is looking to quickly approve Moderna’s COVID-19 vaccine after it was unanimously backed by a panel of experts. Yesterday’s advisory panel meeting voted 20-0 in favour of approving Moderna’s vaccine and although the vote is non-binding, you could probably bet your house on the FDA backing the shot as it rarely goes against …

FDA aims for fast approval of Moderna’s COVID-19 shot after panel vote Read More »

Precision measurement in 2021: Why accuracy is key to the vaccine ‘cold chain’ and disrupting the spread of Covid-19

By creating new networks for 24/7 temperature monitoring, alerts and reporting, the challenges of deploying transportation at ultra-low temperatures can be overcome. This also illustrates the crucial role that precision measurement will have to play.