Category: Pfizer

  • Syapse, Pfizer Extends Collaboration to Generate Real-World Evidence in Breast Cancer

    What You Should Know: – Syapse, a real-world evidence company that informs cancer care, announced that it will extend its collaboration with Pfizer to generate real-world evidence in breast cancer. – This is the third phase of the collaboration, which was first announced in 2019 and renewed in 2021. Generate Real-World Evidence in Breast Cancer […]

  • GSK rejects $68.4bn Unilever bid for consumer health

    GlaxoSmithKline (GSK) claims it has rejected three unsolicited, conditional and non-binding proposals from Unilever to acquire GSK Consumer Healthcare in a deal worth approximately $68.4 billion (£50 billion). The Consumer Healthcare business is a Joint Venture between GSK and Pfizer, with GSK holding a majority controlling interest of 68% and Pfizer 32%. The latest proposal, […]

  • How antivirals provide hope to vulnerable Covid patients

    Pfizer says its recently approved Paxlovid drug has almost 90% success in preventing severe illness if taken soon after infection The recent decision by regulators to approve the antiviral agent Paxlovid for use in the UK adds a formidable new weapon to the arsenal of treatments for Covid-19. Pfizer says the drug has almost 90% […]

  • Sarepta says early filing for DMD gene therapy may be back on

    The development of gene therapies for Duchenne muscular dystrophy has proved to be challenging, but one of the key players – Sarepta – thinks it may have the clinical data needed to file for regulator approval. The new data from the mid-stage Study 102 of SRP-9001 (delandistrogene moxeparvovec) comes from 21 patients who were initially […]

  • Pfizer, Moderna are prepping new vaccines for Omicron

    With evidence growing that the current crop of COVID-19 vaccines are less protective against infection with Omicron, both Pfizer and Moderna have announced plans to develop new versions of their mRNA-based shots that are tailored to the new variant. Pfizer has said that a COVID-19 jab specifically targeting Omicron, as well as other existing variants, […]

  • The power of similarities to accelerate antiviral development for COVID-19

    In April 2020, I wrote a blog post entitled “Exploiting similarities between SARS-CoV-2 and other viruses to accelerate vaccine and therapy development,” where I described research areas leveraging genetic and phenotypic similarities between SARS-CoV-2 and other known viruses. In my quest to find relevant data, I used Reaxys Medicinal Chemistry to generate a list of […]

  • Pfizer, Bayer each strike up deals to add in-vivo gene editing to pipeline mix

    As the annual J.P. Morgan HealthCare Conference kicked off Monday, two pharma giants unveiled deals that expand give them access to in-vivo gene editing technologies. Pfizer is teaming up with Beam Therapeutics to develop new base-editing therapies while Bayer hopes to develop new medicines with the in-vivo CRISPR editing tools of Mammoth Biosciences.

  • Beyond the pandemic: the potential of mRNA technology

    The arrival of COVID-19 brought precious few positives, but one that emerged for the pharmaceutical industry was the emergence and validation of mRNA vaccine technology to prevent disease. Ben Hargreaves takes a look at how the space is currently progressing and in what direction it could be heading in future. The pandemic brought about an […]

  • AstraZeneca goes bigger in amyloidosis with Neurimmune deal

    AstraZeneca has clearly made the rare disease transthyretin amyloidosis (ATTR) a key component of its rare disease pipeline, licensing a second drug candidate in the space of a couple of months. In the latest deal, the pharma group is paying $30 million upfront with another $730 million in milestone’s for global rights to Neurimmune’s NI006, […]

  • Look out GSK, Pfizer and BioNTech are coming for Shingrix

    GlaxoSmithKline places shingles vaccine Shingrix is among its top prospects, with peak sales potential of almost $6 billion. Now, Pfizer and BioNTech are joining forces to try to grab a slice of the market. Having already brought their mRNA-based CVID-19 vaccine Comirnaty to market at breakneck speed, Pfizer and BioNTech are hoping to fast-track a […]

  • FDA clears Pfizer, BioNTech COVID booster for younger teens

    The FDA has authorised the first COVID-19 booster vaccine for teenagers in the 12 to 15 age group, giving the okay for wider use of Pfizer and BioNTech’s Comirnaty shot as it tries to keep the Omicron variant under control. The US regulator has also reduced the time between completion of the first two doses […]

  • UK medicines regulator approves Pfizer’s ‘life-saving’ Covid pill

    Paxlovid found to be ‘safe and effective’ at reducing hospitalisation and death among vulnerable adults Coronavirus – latest updates See all our coronavirus coverage UK regulators have approved Pfizer’s “life-saving” antiviral drug Paxlovid, which boasts nearly 90% success in preventing severe illness among vulnerable adults if taken soon after becoming infected with Covid-19. The Medicines […]

  • Leo puts target on Dupixent in US as FDA clears tralokinumab

    Sanofi and Regeneron have another challenger to their big-selling drug Dupixent for atopic dermatitis, now that the FDA has approved Leo Pharma’s rival antibody tralokinumab. IL-13 inhibitor tralokinumab has been cleared by the US regulator as Adbry as a treatment for moderate-to-severe atopic dermatitis in adults who can’t control symptoms using topical prescription therapies. The […]

  • Covid pills are ‘very promising’ – but what are the challenges in using them?

    Paxlovid and molnupiravir were authorized by the US FDA last week, but supplies of Paxlovid are limited while molnupiravir is less effective than hoped An effective and widely available treatment for Covid would be a major breakthrough for managing the pandemic, but two antivirals recently authorized in the US come with some significant caveats, including […]

  • Pfizer/BioNTech tax windfall brings Mainz an early Christmas present

    German city where early Covid vaccine was developed uses its new-found wealth to slash debt and attract other biotech firms The Pfizer/BioNTech jab is having an unexpected side-effect on the German municipality where scientists first developed it: for the first time in three decades the city of Mainz expects to become debt-free thanks to the […]

  • More options for Covid treatments in January as FDA approves two antiviral pills

    The approval comes as reports of shortages in monoclonal antibody treatment arise and cases spike People at greater risk of becoming seriously ill from Covid-19 will likely have more treatment options in January. That’s the forecast in the wake of the US Food and Drug Administration’s approval this week of the first two antiviral pills […]

  • FDA authorizes Merck antiviral, which joins Pfizer pill as oral option for Covid-19

    Merck antiviral drug molnupiravir received emergency authorization, joining Pfizer’s Paxlovid as the only authorized oral antiviral drugs for treating Covid-19. Though the Merck and Pfizer antivirals appear to work against the omicron variant, FDA officials stressed that these drugs are authorized only for certain patients and they are not a substitute for vaccination.

  • Pfizer pips Merck to first oral COVID antiviral okay in US

    Pfizer’s Paxlovid has become the first oral antiviral for COVID-19 to be authorised for emergency use by the FDA, as the US braces itself for a surge in Omicron cases over the holiday period. The green light means that Paxlovid – based on nirmatrelvir (formerly PF-07321332) and ritonavir – has been cleared for use in […]

  • Pfizer pauses Duchenne gene therapy trial after patient death

    Pfizer has called a halt to a clinical trial of its gene therapy for Duchenne muscular dystrophy as it investigates the unexpected death of a young male patient. In an update posted today the pharma giant said “we do not yet have complete information and are actively working with the trial site investigator to understand […]

  • FDA expected to approve Covid treatment pills within days

    Agency will give go-ahead for Pfizer and Merck to launch groundbreaking oral treatments perhaps this week US federal regulators are expected to approve the first pills to treat Covid-19 as early as this week, it was reported on Tuesday. According to sources quoted by Bloomberg News, the Food and Drug Administration (FDA) will give the […]

  • As Omicron cases rise, EMA backs early use of Pfizer’s Paxlovid

    The EMA’s human medicines committee has said that EU member states can start to offer Pfizer’s oral antiviral Paxlovid as a treatment for people with COVID-19 outside hospital, ahead of a formal approval for the drug. The decision comes amid rising rates of infection and deaths due to COVID-19 across the EU, and with 529 […]

  • Pfizer says pill is effective in protecting against severe disease from Covid

    Experimental antiviral pill Paxlovid is also effective against the Omicron variant, company announces A pill manufactured by the prominent Covid-19 vaccine provider Pfizer is highly effective in protecting against severe disease from coronavirus, the company said on Tuesday. The experimental antiviral pill Paxlovid is also effective against the Omicron variant that is spreading rapidly across […]

  • Patients ‘29% less likely to be hospitalised with Omicron’

    Data from a real-world study South Africa has indicated that the Omicron variant of COVID-19 is 29% less likely to cause hospitalisation among infected adults than other strains – although the researchers behind the work stress the findings are preliminary. The results – released by healthcare insurance group Discovery SA and the South African Medical […]

  • Flush with COVID cash, Pfizer tables $6.7bn bid for Arena

    Pfizer has found another use for the windfall profits it is making from it BioNTech-partnered COVID-19 vaccine, agreeing to buy Arena Pharma and its late-stage ulcerative colitis drug etrasimod. The $100-per-share deal values Arena at around $6.7 billion, and gives Pfizer an entry into the oral S1P receptor modulator category that puts it in contention […]

  • Pfizer: $6.7B Arena buyout complements rather than replaces JAK drugs

    Sales of blockbuster Pfizer drug Xeljanz are under pressure from a stronger safety warning placed across that drug’s entire class. In acquiring Arena Pharmaceuticals for $6.7 billion, Pfizer gets a lead compound with a different and potentially safer approach to treating inflammatory conditions.

  • BioNTech CEO: omicron is partial escape variant, but booster may restore protection

    Preliminary data suggest the BioNTech and Pfizer Covid-19 vaccine may have diminished protection against the omicron variant, but that levels of neutralizing antibodies can be restored with a third shot. Real-world data are needed to further assess the vaccine’s efficacy against the new variant and whether an omicron-specific version of the shot is needed.

  • Omicron may evade Pfizer/BioNTech COVID jab, says study

    Preliminary study results from South Africa have suggested that antibodies stimulated by Pfizer and BioNTech’s Comirnaty are less effective against the new COVID-19 variant Omicron. A study by the African Health Research Institute (AHRI) has found that the less of immune protection was “extensive but incomplete,” meaning that some level of immunity was retained against […]

  • AZ gets closer to Ionis, licensing amyloidosis drug in $3.6bn deal

    AstraZeneca has snapped up another Ionis-discovered drug for its pipeline, this time phase 3 candidate eplontersen for the disease transthyretin amyloidosis (ATTR). The deal is another sizeable one too, with an upfront fee of $200 million, another $485 million tied to regulatory approvals, and up to $2.9 billion in milestones depending on sales levels if […]

  • ‘Wall of secrecy’ in Pfizer contracts as company accused of profiteering

    US company faces scrutiny over Covid profits after UK agrees to secrecy clause Coronavirus – latest updates See all our coronavirus coverage Ministers have agreed a secrecy clause in any dispute with the drugs manufacturer Pfizer over Britain’s Covid vaccine supply. Large portions of the government’s contracts with the company over the supply of 189m […]

  • Trial closes gap between Bayer’s Nubeqa and rivals in prostate cancer

    Bayer’s Nubeqa is making headway as a treatment for castration-resistant prostate cancer (CRPC), but could be on track to expand the eligible patient population for the drug thanks to new phase 3 data. Just released results from the ARASENS trial show that adding Nubeqa (darolutamide) to docetaxel chemotherapy and androgen deprivation therapy (ADT) to switch […]

  • AWS and Pfizer Accelerate Drug Development and Clinical Manufacturing

    What You Should Know: Amazon Web Services (AWS) announced it is working with Pfizer to create innovative, cloud-based solutions to accelerate drug development and clinical manufacturing for testing in clinical trials. Today, Amazon Web Services, Inc. (AWS) announced that it is working with Pfizer to create innovative, cloud-based solutions with the potential to improve how […]

  • UK government rubberstamps millions of extra COVID vaccines

    The UK government has placed a 114 million-dose order with Pfizer/BioNTech and Moderna – sufficient to provide two doses to every person in Britain – in a bid to future-proof against COVID-19 variants.  Health and Social Care Secretary, Sajid Javid, announced the move as researchers race to uncover the effect of existing vaccines on the Omicron […]

  • UK ministers secure 114m more Covid vaccines for next two years

    Extra Pfizer/BioNTech and Moderna jabs for 2022 and 2023 ordered to ‘future proof’ vaccine programme Coronavirus – latest updates See all our coronavirus coverage Ministers in the UK have secured new contracts to buy 114m more Covid-19 vaccines for the next two years. The deals, for 2022 and 2023, were accelerated after the emergence of […]

  • Truepill preps launch of virtual COVID-19 service for oral antivirals

    Telehealth, diagnostics and pharmacy business Truepill will launch a new virtual care platform in the coming weeks that it says will provide “end-to-end” care for people with COVID-19. The on-demand, online service will combine virtual consultations and next-day delivery of oral antiviral medicines – assuming those become available to patients in the US. Closest to […]

  • Merck’s oral COVID drug squeaks past FDA advisory committee

    An FDA advisory committee voted by 13 to 10 to recommend emergency-use authorisation for Merck & Co and Ridgeback’s oral antiviral molnupiravir for mild-to-moderate COVID-19, saying it would be useful for some high-risk patients. The panel met shortly after updated results from the phase 3 MOVE-OUT trial of the drug showed it was less effective […]

  • GSK poaches Pfizer exec Dormitzer as new vaccines R&D chief

    GlaxoSmithKline has found a replacement for head of vaccines R&D Emmanuel Hanon, who left the company for a US biotech earlier this year, hiring Phil Dormitzer from Pfizer. Phil Dormitzer Dormitzer is due to take up his new role at GSK on Friday, and will report to chief scientific officer and group president of R&D […]

  • Moderna boss predicts current vaccines may be less effective against Omicron covid

    Stock markets dip as CEO says firms may struggle in targeting both new strain and existing Covid variants The chief executive of the US drugmaker Moderna has predicted that existing vaccines will be less effective against Omicron than they have been against the Delta version, sending global stock markets sharply lower. Stéphane Bancel said while […]

  • Concern about Covid-19 variant Omicron centers on spike protein mutations

    The new Covid-19 variant, named Omicron, has mutations that could help it evade antibodies produced by the immune system. Scientists are conducting lab tests to better understand this new variant and pharmaceutical companies are testing how existing vaccines, as well as those in development, measure up the new mutations.

  • Pharma pledges rapid response to Omicron COVID variant

    With governments around the world announcing measures to curb the new B.1.1.529 variant of COVID-19 – now christened Omicron – leading vaccine manufacturers have said they are poised to develop new shots if needed. News of the new variant emerged last week, and has resulted in travel bans being imposed on various African countries by […]

  • Fall in efficacy of Merck’s molnupiravir puts Pfizer in driver’s seat

    Merck & Co has reported new data with its oral antiviral molnupiravir that suggests it is not as effective against COVID-19 as originally hoped. An updated readout from the MOVE-OUT study of molnupiravir shows that the original 48% reduction in the risk of hospitalisation or death in people with mild or moderate COVID-19 at high […]

  • Could safety scupper Ionis, Pfizer’s cholesterol drug vupanorsen?

    Ionis has reported phase 2b trial data for its Pfizer-partnered antisense drug vupanorsen for cholesterol lowering that showed it met its main efficacy targets, but raised a few safety concerns as well. The top-line results of the TRANSLATE-TIMI 70 study – in dyslipidaemia patients with elevated non-HDL cholesterol and triglycerides – showed that vupanorsen was […]

  • EU authorises first COVID-19 vaccine for 5 to 11 year olds

    The European Medicines Agency (EMA) has approved Pfizer and BioNTech’s COVID-19 vaccine Comirnaty for children between the ages of five and 11, as EU countries struggle to cope with rising infection rates. The EU regulator said that the under-12s should get a lower dose of the vaccine – 10 mcg rather than 30 mcg – […]

  • FDA, CDC COVID jab decisions ‘will simplify booster messaging’

    Three hurdles to allowing booster COVID-19 vaccinations for all adults in the US fell in swift succession on Friday, clearing the way for wider use of the Pfizer/BioNTech and Moderna shots. The FDA cleared emergency use of the two vaccines on Friday, which was swiftly followed by a recommendation from a Centres for Disease Control […]

  • Pfizer gets bumper $5.3bn order from US for oral COVID drug

    Already making big profits from its COVID-19 vaccine, Pfizer looks set to bolt on another big revenue stream with its oral antiviral drug Paxlovid after scoring a $5.3 billion order for the drug from the US government. The deal is dependent on Paxlovid (PF-07321332/ritonavir) being granted either emergency use authorisation (EUA) or full approval, although […]

  • Pfizer files oral COVID pill in US, signs access deal for 95 countries

    Armed with impressive new data for its oral antiviral Paxlovid, Pfizer has filed for emergency use authorisation as a COVID-19 treatment in the US – and signed a deal to allow other manufacturers to make it in some lower-income countries. Paxlovid – based on new protease inhibitor PF-07321332 and HIV drug ritonavir – was found […]

  • Pfizer strikes deal to allow generic versions of its Covid pill for world’s poor

    Under the licensing agreement, Pfizer will not receive royalties from the manufacturers, making the treatment cheaper See all our coronavirus coverage US pharmaceutical giant Pfizer has announced a deal to make its prospective antiviral Covid-19 pill available more cheaply in the world’s least-wealthy countries. Pfizer will allow generic manufacturers to supply its promising Paxlovid pill […]

  • The Guardian view on vaccine justice: what the world needs now | Editorial

    While some in the west are triple-dosed, the vast majority of health workers in Africa remain unprotected. Gestures won’t close the gulf AstraZeneca’s halo has slipped. When it partnered with Oxford University, it promised to sell Covid vaccines at cost while the pandemic lasted; now it is signing its first for-profit deals, saying it believes […]

  • PharmaShots Weekly Snapshots (November 08 – 12, 2021)

    Eisai Presents Results of Lecanemab in P-IIb Study 201 Study for the Treatment of Alzheimer’s Disease at CTAD 2021 Published: Nov 12, 2021 | Tags: Eisai, Lecanemab, P-IIb, Study 201 Study, Alzheimer’s Disease, CTAD 2021 Novo Nordisk’s Wegovy (semaglutide) Receives CHMP’s Recommendation for Approval to Treat Obesity Published: Nov 12, 2021 | Tags: Novo Nordisk, […]

  • Pfizer strikes $1.2bn licensing deal for Biohaven migraine drug

    Pfizer has bolstered its central nervous system (CNS) drugs portfolio with a $1.2 billion deal to claim rights outside the US to Biohaven’s Nurtec ODT, an oral therapy for migraine. The agreement includes a sizeable $500 million upfront payment, reflecting that Nurtec ODT (rimegepant) is already FDA-approved for treating acute migraine with and without aura […]

  • Biohaven’s migraine progress pays off with a Pfizer marketing pact for two drugs

    Biohaven Pharmaceuticals has seen strong U.S. market uptake for its oral migraine drug, Nurtec. With regulatory decisions looming around the world, the company has landed the marketing muscle of Pfizer, which is paying $500 million up front for the right to market that drug and another clinical-stage compound outside of the U.S.

  • Pfizer’s pill cuts COVID deaths and hospitalisations by 90%

    An oral antiviral drug developed by Pfizer has been shown to dramatically cut the risk of hospitalisation or death from COVID-19 when given in the early stages of infection. The phase 3 trial found that Paxlovid – which combines new protease inhibitor PF-07321332 with already-approved HIV drug ritonavir – reduced the risk of hospitalisation or […]

  • Pfizer Covid pills highly effective at preventing deaths, trial suggests

    Antiviral pill taken at home can cut rate of hospital admission and death by nearly 90%, says drugmaker Coronavirus – latest updates See all our coronavirus coverage Pfizer has said that its experimental antiviral pill for Covid-19 cut rates of hospital admission and death by nearly 90%, as the drugmaker joins the race to bring […]

  • US backs COVID jabs for young kids – should others follow?

    The US is now pressing ahead with plans to extend its COVID-19 vaccination campaign to younger children aged five and over, prompting a debate about the policy in other countries. It follows the decision by Centers of Disease Control and Prevention (CDC) Director Rochelle Walensky to back a widening of vaccination shot from the current […]

  • Pharma group will develop ‘digital endpoint’ for atopic dermatitis

    The development of digital medicine requires valid endpoints that can be used in clinical trials, and a consortium of pharma companies has just identified a new one for atopic dermatitis. Working with the Digital Medicine Society (DiMe), the drugmakers – AbbVie, Janssen, Novartis, Pharma and UCB – will work on the development of nocturnal scratch […]

  • Pfizer’s COVID jab sales swell again, with $36bn forecast for 2021

    Rocketing sales of COVID-19 vaccine Comirnaty have allowed Pfizer to raise its full-year forecasts for the shot once again to a whopping $36 billion, more than double its predictions just a few months ago. Fuelled by extensions to vaccination programmes to include children and booster shots, the BioNTech-partnered jab made nearly $13 billion in the […]

  • Pfizer raises Covid-19 vaccine sales forecast to $36bn for 2021

    US drugmaker expects to manufacture 3bn doses of vaccine with BioNTech this year Coronavirus – latest updates See all our coronavirus coverage The US drugmaker Pfizer has lifted its 2021 forecast for revenues from its Covid vaccine to $36bn (£26.3bn), after bumper sales in the third quarter. The Covid jab, called Comirnaty and developed with […]

  • FDA delays review of Moderna COVD jab in adolescents

    The FDA has said it needs more time to review Moderna’s application for emergency use of its COVID-19 vaccine mRNA-1273 in children aged 12 to 17, as it looks at data on heart inflammation in people receiving the shot. The decision leaves Moderna playing catch-up with Pfizer and BioNTech, whose Comirnaty vaccine was approved for […]

  • PharmaShots Weekly Snapshots (October 25 – 29, 2021)

    ADC Reports EMA’s Validation of MAA for Zynlonta to Treat R/R Diffuse Large B-Cell Lymphoma Published: 29 Oct, 2021 | Tags: ADC, EMA, MAA, Zynlonta, R/R Diffuse Large B-Cell Lymphoma Impact Receives US FDA’s IND Clearance for IMP9064 to Treat Solid Tumor Published: 29 Oct, 2021 | Tags: Impact, US, FDA, IND, IMP9064, Solid Tumor […]

  • CDC director backs COVID-19 jab for 5 to 11s, plus a fourth shot

    The US looks set to see a big expansion of the country’s COVID-19 vaccination drive, with shots looking likely for children aged five to 11 as well as a fourth dose for adults who are immunocompromised. FDA advisors gave a green light to Pfizer and BioNTech’s COVID-19 vaccine Comirnaty for children in that younger age […]

  • FDA advisors mull use of Pfizer/BioNTech COVID-19 jab in kids

    FDA advisors will meet later today discuss the possibility of authorising Pfizer and BioNTech’s COVID-19 vaccine Comirnaty in children as young as five years old. If the Vaccines and Related Biological Products Advisory Committee (VRBPAC) gives the go-ahead, the FDA could approve emergency-use of Comirnaty in five to 11-year-olds in a matter of days, extending […]

  • The “Secret Sauce” – A Comparison of TSMC and Pfizer

    By MIKE MAGEE This week’s Tom Friedman Opinion piece in the New York Times contained a title impossible to ignore: “China’s Bullying Is Becoming a Danger To The World and Itself.” The editorial has much to recommend it. But the item that caught my eye was Friedman’s full-throated endorsement of Taiwan’s “most sophisticated microchip manufacturer in the […]

  • PharmaShots Weekly Snapshots (October 18 – 22, 2021)

    LEO Reports 16-week Results of Tralokinumab in P-III ECZTRA 6 Trial for the Treatment of Moderate-to-Severe Atopic Dermatitis Published: 22 Oct, 2021 | Tags: LEO, Tralokinumab, P-III, ECZTRA 6 Trial, Atopic Dermatitis Marinomed Biotech Signs a License Agreement with Luoxin to Commercialize Budesolv (budesonide nasal spray) in Greater China Published: 22 Oct, 2021 | Tags: […]

  • Pfizer’s Prevnar 20 (Pneumococcal 20-Valent Conjugate Vaccine) Receives the CDC’s Advisory Committee Recommendation for Invasive Disease and Pneumonia

    Shots: The CDC’s ACIP has voted to recommend Prevnar 20 (Pneumococcal 20-valent Conjugate Vaccine) to protect adults against invasive disease and pneumonia caused by the 20 S. pneumoniae serotypes The ACIP has recommended one dose of Prevnar 20 for adults aged ≥65 & for ≥19yrs. with risk conditions who have not previously received a pneumococcal […]

  • Pfizer asks US to allow Covid vaccines for children ages five to 11

    Jabs could begin within weeks if US government approves request, with children getting a third of dose given to adults Pfizer asked the US government Thursday to allow use of its Covid-19 vaccine in children ages five to 11 – and if regulators agree, shots could begin within a matter of weeks. Many parents and […]

  • Pfizer Signs an Option and License Agreement with Voyager to Develop and Commercialize Gene Therapies for Neurologic and Cardiovascular Diseases

    Shots: Voyager to receive $30M up front, $20M as exercise fees for 2 options (exercisable within 12mos.) & ~$580M as development, regulatory & commercial milestones related to licensed products including 2 undisclosed Pfizer’s transgenes along with royalties based on sales of products including licensed capsids Pfizer gets the right to assess novel capsids for CNS […]

  • Could Pfizer’s Inlyta have a role in Alzheimer’s disease?

    Pfizer’s tyrosine kinase inhibitor Inlyta is already a cornerstone of treatment for some forms of cancer, but could have potential as a therapy for Alzheimer’s disease as well, according to scientists in Canada. The team – from the University of British Columbia – are particularly excited about their findings because the drug could represent an […]

  • EU backs broader use of Comirnaty as COVID booster than US

    The EMA has given the go-ahead to the use of Pfizer and BioNTech’s COVID-19 vaccine Comirnaty as a booster for all people aged 18 or more, but says EU member states must decide for themselves whether to make a third dose available to their citizens. The regulator’s human medicines committee (CHMP) said that a third […]

  • Coronavirus treatments: the potential ‘game-changers’ in development

    After positive clinical trials for antiviral drug Molnupiravir, it joins other medicines that have shown promise Coronavirus – latest updates See all our coronavirus coverage The first clinical trial results showing a positive effect for a pill that can be taken at home has been hailed as a potential gamechanger that could provide a new […]

  • Booster data backs Pfizer, Valneva Lyme disease vaccine

    Prospects for Valneva’s COVID-19 vaccine are up in the air, but another candidate partnered with Pfizer looks increasingly like it could fill the void of an effective shot for Lyme disease. New phase 2 data with their VLA15 vaccine shows that antibody responses from an initial three-dose regimen are initially high, although they start to […]

  • PharmaShots Weekly Snapshots (September 20 – 24, 2021)

    Everest’s SPR206 Receives the NMPA’s IND Approval for the Treatment of MDR Gram-Negative Bacterial Infections Published: Sept 24, 2021 | Tags: Everest, SPR206, NMPA, IND, Approval, MDR Gram-Negative Bacterial Infections GE Healthcare to Acquire BK Medical for ~ $1.45B Published: Sept 24, 2021 | Tags: GE Healthcare, Acquire, BK Medical, ~ $1.45B Roche Presents Results […]

  • Australia shores up Pfizer supply after days of uncertainty

    John Frewen says company advised the government on Friday they would deliver the full 9m doses in October Australia will get its full supply of Pfizer next month, with the head of the country’s rollout saying the company had confirmed it would provide 9m doses in October as planned. After days of uncertainty over Pfizer […]

  • CDC overrules its advisors, backing COVID booster for health workers

    The Centre for Disease Control and Prevention (CDC) in the US has backed booster doses of Pfizer and BioNTech’s COVID-19 vaccine Comirnaty in line with its recent FDA approval, overruling the advice of its own expert advisors. The CDC’s Advisory Committee on Immunisation Practices (ACIP) voted unanimously yesterday to recommend a third dose of Comirnaty […]

  • FDA approves Pfizer COVID booster jabs for higher-risk groups

    Just days after its advisory committee meeting voted to approve a third dose of Pfizer and BioNTech’s COVID-19 vaccine, the FDA has followed through and cleared the shot. The FDA has amended the emergency use authorisation (EUA) for Comirnaty in line with its experts’ advice – for people aged over 65 and other adults at […]

  • 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 […]

  • 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 […]

  • 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

    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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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) […]

  • 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 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’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 […]

  • 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 […]

  • 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 […]

  • 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)

    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 […]

  • 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 […]

  • 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 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 […]

  • 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 […]

  • 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: […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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, […]

  • 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 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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) […]

  • 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 […]

  • 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 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 […]

  • 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 […]

  • 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 […]

  • 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: […]

  • 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. […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 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 […]

  • 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 […]

  • 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 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 […]

  • 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: […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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. […]

  • 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 […]

  • 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 […]

  • Pfizer, BioNTech seek full FDA approval of Covid-19 vaccine

    The messenger RNA vaccine developed by Pfizer and BioNTech has been formally submitted for FDA approval. The application comes amid calls for all vaccine companies to waive patent protections on these products so that others will be able to manufacture them.

  • 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 […]

  • 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 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 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. […]

  • 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 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 […]

  • 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 […]

  • 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, […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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. […]

  • 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. […]

  • 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 […]

  • 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)

    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, […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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: […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 | […]

  • 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 […]

  • 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 […]

  • 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 […]