BioNTech

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 …

EU backs broader use of Comirnaty as COVID booster than US Read More »

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 …

PharmaShots Weekly Snapshots (September 20 – 24, 2021) Read More »

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 …

CDC overrules its advisors, backing COVID booster for health workers Read More »

Pfizer and BioNTech’s COVID-19 Vaccine Booster Receive the US FDA’s EUA for the Treatment of COVID-19

Shots: The US FDA has issued a EUA for the COVID-19 booster vaccine (administered at least 6mos. after completion of primary 2 doses) to prevent COVID-19 in individuals aged ≥65yrs. & 18 through 64yrs. of age who at high risk of severe COVID-19 The EUA is based on clinical data that showed higher neutralizing Ab …

Pfizer and BioNTech’s COVID-19 Vaccine Booster Receive the US FDA’s EUA for the Treatment of COVID-19 Read More »

FDA authorizes Pfizer Covid-19 vaccine booster shots, but only for certain groups

The FDA has authorized dosing of booster shots of Pfizer and BioNTech’s Covid-19 vaccine. Consistent with the recommendations of an FDA advisory committee, the agency’s amendment to the emergency authorization covers only certain groups at high risk of infection and complications from the virus.

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 …

FDA approves Pfizer COVID booster jabs for higher-risk groups Read More »

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 …

Amnesty says COVID jab producers are causing human rights crisis 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.

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 »

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.

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 »

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 »

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 »

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 »

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 »

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 »

Lessons learned from the Covid vaccine development process

As the world’s focus has turned to getting the COVID-19 vaccines out as widely and rapidly as possible, it’s easy to almost forget about the incredible global effort that developed them in record time. But it is important to take some time to reflect on the process that got us here, so that we can …

Lessons learned from the Covid vaccine development process 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 »

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 »

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 »

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 »

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 »

PharmaShots Weekly Snapshots (July 26 – 30, 2021)

Roche Publishes the Results of Evrysdi (risdiplam) in FIREFISH Study to Treat of Type 1 SMA at NEJM Published: July 30, 2021 | Tags: Roche, Evrysdi, risdiplam, FIREFISH Study, Type 1 SMA, NEJM BeiGene Reports Results of Brukinsa (zanubrutinib) in P-III SEQUOIA Trial for the Treatment of Chronic Lymphocytic Leukemia Published: July 30, 2021 | …

PharmaShots Weekly Snapshots (July 26 – 30, 2021) Read More »

BioNTech Plans to Initiate the Clinical Study of Malaria and Tuberculosis Vaccines in 2022

Shots: BioNTech unveils the plan to develop the first mRNA-based vaccine to prevent malaria with anticipated initiation of the clinical study by the end of 2022 The company intends to set up a large vaccine production hub in Africa with the help of local partners and transfer its mRNA technology to Africa. These efforts of …

BioNTech Plans to Initiate the Clinical Study of Malaria and Tuberculosis Vaccines in 2022 Read More »

BioNTech’s mRNA vaccine drive now includes malaria, TB shots

Flushed with the success of its COVID-19 vaccine, BioNTech has pressed the accelerator on the development of shots for other infectious diseases, and now plans to take malaria and tuberculosis candidates into the clinic next year. Human testing of the malaria shot should get underway by the end of 2022, according to the German biotech, …

BioNTech’s mRNA vaccine drive now includes malaria, TB shots 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 »

BioNTech Signs a Purchase Agreement to Acquire Kite’s Cell Therapy, R&D Platform and Manufacturing Facility in Gaithersburg, MD

Shots: Kite will receive a one-time upfront to purchase Kite’s individualized solid tumor neoantigen TCR discovery platform, R&D & clinical manufacturing facility in Gaithersburg. The Transaction is expected to be close at the end of Jul’21 BioNTech will use the Kite’s facility to support clinical trials in the US & will add its cell therapy …

BioNTech Signs a Purchase Agreement to Acquire Kite’s Cell Therapy, R&D Platform and Manufacturing Facility in Gaithersburg, MD Read More »

BioNTech grows in cell therapies, buying Kite’s TCR platform

BioNTech has found a use for some of the windfall cash it has raked in from its COVID-19 vaccine, agreeing a deal to buy Kite Pharma’s entire neoantigen T cell receptor (TCR) platform for solid tumours, and an associated manufacturing plant. There’s no value attached to the deal – even though BioNTech is a publicly …

BioNTech grows in cell therapies, buying Kite’s TCR platform 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 »

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 »

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 »

BioNTech Reports First Patient Dosing in P-II Clinical Trial of BNT111 to Treat Advanced Melanoma

Shots: The first patient has been dosed in a P-II cancer vaccine trial evaluating the efficacy, tolerability & safety of BNT111 + Libtayo in combination or as monothx in 120 patients with anti-PD1 r/r unresectable Stage III or IV melanoma in EU. The company also plans to start P-II trial in 2 additional programs with …

BioNTech Reports First Patient Dosing in P-II Clinical Trial of BNT111 to Treat Advanced Melanoma 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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 & 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.

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 …

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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 »

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 …

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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 »

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 »

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 »

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 »

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 »

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 »

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 »

Moderna and BioNTech – who are they?

Moderna and BioNTech, two rising stars in biotech, were in the limelight this year with their pioneering mRNA vaccines against COVID-19. Just who are these companies and who is behind them, asks Richard Staines. A year ago, the names Moderna and BioNTech were known mainly to those who followed biotech and pharma dealings. But the …

Moderna and BioNTech – who are they? 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.

PharmaShots Weekly Snapshots (Dec 14-18, 2020)

Sandoz to Launch Hyrimoz (biosimilar, adalimumab) in Canada Published: Dec 17, 2020 | Tags: Authorization, Biosimilar, canada, health, Humira, Hyrimoz, Launch, receives, Sandoz Amgen’s Riabni (biosimilar, rituximab) Receives the US FDA’s Approval for Multiple Diseases Published: Dec 17, 2020 | Tags: Adult, Amgen, approval, Biosimilar, CLL, GPA, MPA, NHL, patients, receives, RIABNI, Rituxan, Rituximab, rituximab-arrx, …

PharmaShots Weekly Snapshots (Dec 14-18, 2020) 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.

Trials of Valneva COVID-19 vaccine begin in UK

Trials of a fifth COVID-19 vaccine have begun in the UK, as IT issues threaten to delay the roll-out of the shot from Pfizer/BioNTech. France’s Valneva begun the phase 1/2 clinical study of the inactivated vaccine candidate VLA2001 in sites across the UK, supported by the National Institute for Health Research (NIHR). It is the …

Trials of Valneva COVID-19 vaccine begin in UK Read More »

Pfizer/BioNTech COVID-19 vaccinations start across the US

Hospitals in the US have started vaccinating their front-line staff against COVID-19, as deaths in the country crossed the 300,000 threshold with more than 200,000 new cases reported yesterday. Shipments of Pfizer/BioNTech’s mRNA vaccine BNT-162b are being shipped to hundreds of hospitals and other distribution facilities across the US, with the first three million doses …

Pfizer/BioNTech COVID-19 vaccinations start across the US Read More »

Family doctors begin COVID-19 immunisation drive in UK

The roll-out of the biggest vaccination programme in the history of the UK’s NHS is gathering pace, as family doctors and their teams begin taking delivery of Pfizer/BioNTech’s COVID-19 shot. In a statement the NHS said that GP practices in more than 100 parts of the country are taking delivery of the vaccine today. Some …

Family doctors begin COVID-19 immunisation drive in UK Read More »

Pfizer and BioNTech’s BNT162b2 Receives the US FDA’s EUA to Prevent COVID-19

Shots: Pfizer & BioNTech received the US FDA’s EUA for BNT162b2 for patients aged ≥16yrs with COVID-19. The companies are gathering additional data & prepared to file a planned BLA with the US FDA anticipating full approval in 2021 The EUA is based on P-III pivotal study demonstrating 95% efficacy in participants without prior SARS-CoV-2 …

Pfizer and BioNTech’s BNT162b2 Receives the US FDA’s EUA to Prevent COVID-19 Read More »

PharmaShots Weekly Snapshots (Dec 7-11, 2020)

Roche Launches Elecsys SARS-CoV-2 Antigen Test to Support High-Volume COVID-19 Testing Published: Dec 11, 2020 | Tags: Antigen, COVID-19, High, Laboratory, Launch, patients, Roche, SARS-CoV-2, Support, Suspected, Test, Testing, Volume Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 in Japan Published: Dec 10, 2020 | Tags: Casirivimab, Chugai, Commercialization, COVID-19, Development, Imdevimab, In-License Agreement, Japan, Roche, …

PharmaShots Weekly Snapshots (Dec 7-11, 2020) Read More »

FDA advisers vote in favour of Pfizer/BioNTech COVID-19 shot

Advisers to the FDA have voted in favour of approving Pfizer and BioNTech’s COVID-19 vaccine, with a near-unanimous backing from an expert committee. While the decision of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) is non-binding, the FDA seldom goes against the ruling of its advisers when making regulatory decisions. However has were …

FDA advisers vote in favour of Pfizer/BioNTech COVID-19 shot Read More »

Cyberattack targets EMA, hacks COVID-19 vaccine data

The European Medicines Agency (EMA) says it suffered a cyberattack, with documents relating to a Pfizer and BioNTech’s COVID-19 vaccine accessed. In a terse statement, the EU regulator confirmed its security had been breached and said it had launched an investigation with law enforcement, but would not be providing any additional information while that probe …

Cyberattack targets EMA, hacks COVID-19 vaccine data Read More »

Pfizer and BioNTech ‘s BNT162b2 Receive Health Canada Authorization to Combat COVID-19

Shots: Health Canada has granted authorization under interim order for the emergency use of BNT162b2. The distribution of the vaccine in Canada will be prioritized according to the populations identified in guidance from the NACI BioNTech will hold the regulatory approval in Canada while Pfizer will have the commercialization rights. The approval is based on …

Pfizer and BioNTech ‘s BNT162b2 Receive Health Canada Authorization to Combat COVID-19 Read More »

Coronavirus vaccine may have allergy warning in US, says expert

The US government’s coronavirus vaccine chief has said that Pfizer/BioNTech’s vaccine could carry a warning that it should be avoided by people who are prone to serious allergic reactions. Moncef Slaoui, co-head of the US government’s Operation Warp Speed COVID-19 vaccine programme, made the comments after the UK drugs regulator advised those with severe allergies …

Coronavirus vaccine may have allergy warning in US, says expert Read More »

FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel

Reviewers from the FDA have given their blessing to the Pfizer/BioNTech COVID-19 vaccine ahead of a key meeting tomorrow – but the regulator noted that there are still uncertainties about whether the shot can stop the disease from spreading. The gist of a briefing document published from FDA reviewers ahead of an expert advisory board …

FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel Read More »

First COVID-19 vaccinations begin in UK hospitals

A 90-year-old woman has become the first person given a COVID-19 vaccine as part of the UK’s mass vaccination programme. Margaret Keenan was given the injection at 06:31 this morning at University Hospitals Coventry and Warwickshire NHS Trust. Keenan turns 91 next week and the BBC said she described receiving the shot as “the best …

First COVID-19 vaccinations begin in UK hospitals Read More »

UK faces “V-Day” and largest ever vaccination programme

Tuesday has been dubbed “V-day” in the UK, when the first doses of Pfizer/BioNTech’s coronavirus vaccine will be distributed to the public outside of a clinical trial. Health secretary reportedly Matt Hancock came up with the wartime analogy to describe what will be the largest scale vaccination programme in the country’s history. The UK last …

UK faces “V-Day” and largest ever vaccination programme Read More »

PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020)

Richter Acquires Janssen’s Evra Transdermal Contraceptive Patch Assets for $263.5M Published: Dec 3, 2020 | Tags: Asset Purchase Agreement, Evra, Gedeon Richter, Janssen Pharmaceutical, Signs, Transdermal Contraceptive Patch Assets, Treat Jazz Pharma and PharmaMar’s Zepzelca Fail to Meet its Primary Endpoint in P-III ATLANTIS Study for SCLC Published: Dec 3, 2020 | Tags: ATLANTIS, Doxorubicin, …

PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020) Read More »

Pfizer & BioNTech Receives MHRA’s EUA for BNT162b2 Against COVID-19

Shots: Pfizer & BioNTech reports that the MHRA in the UK has granted a temporary authorization for the EU for BNT162b2 against COVID-19. The distribution of vaccine will be prioritized according to the populations identified in guidance from the JCVI The MHRA’s decision is based on a rolling submission, including data from the P-III study, …

Pfizer & BioNTech Receives MHRA’s EUA for BNT162b2 Against COVID-19 Read More »

Social media erupts as anti-vaxxers respond to COVID-19 vaccine approval

In the midst of the jubilation about the UK’s emergency approval of Pfizer/BioNTech’s COVID-19 shot in the UK came the depressingly inevitable round of anti-vaccine social media activity and lobbying. The green light for BNT162b was swiftly followed by posts on Twitter likening the vaccine to thalidomide – the drug that notoriously resulted in thousands …

Social media erupts as anti-vaxxers respond to COVID-19 vaccine approval Read More »

Pfizer/BioNTech to deliver COVID-19 vaccine to UK after approval

Pfizer and BioNTech are preparing to deliver their COVID-19 vaccine to the UK after the country’s drugs regulator became the first authority in the world to approve it. As predicted by pharmaphorum, the regulator was able to move faster than its counterparts from the European Medicines Agency, who are also conducting a separate review of …

Pfizer/BioNTech to deliver COVID-19 vaccine to UK after approval Read More »

Pfizer/BioNTech say COVID-19 vaccine could be approved in Europe by year-end

Pfizer and BioNTech have filed their COVID-19 vaccine with the European medicines regulator, paving the way for a potential approval before the end of the year. The filing for a conditional marketing authorisation completed the rolling submission process that began on October 6. The companies initially filed the nonclinical data and other technical data, followed …

Pfizer/BioNTech say COVID-19 vaccine could be approved in Europe by year-end Read More »

UK appoints COVID-19 vaccine rollout minister as country preps for launch

The UK has appointed Nadhim Zahawi as vaccine rollout minister as the country prepares for a potential approval of Pfizer/BioNTech’s ground-breaking COVID-19 vaccine. According to press reports, the UK’s drug regulator, the Medicines and Healthcare products Regulatory Authority (MHRA) could become one of the first bodies to approve the vaccine. According to the Financial Times, …

UK appoints COVID-19 vaccine rollout minister as country preps for launch Read More »

PharmaShots Weekly Snapshot (Nov 23 – 27, 2020)

Merck Collaborates with Siemens for the Digitalization of Production Published: Nov 26, 2020 | Tags: Agreement, Collaborative, Digitalization, Merck, Siemens, Sign CoSara Receives CDSCO’s Approval for its Saragene COVID-19 2-Gene Multiplex Test Published: Nov 26, 2020 | Tags: approval, CDSCO, Co-Diagnostics JV CoSara, COVID-19 2-gene multiplex RT-PCR, India, Manufacture, receives, Saragene, Sell, Test PostEra Collaborates …

PharmaShots Weekly Snapshot (Nov 23 – 27, 2020) Read More »

BioNTech and Fosun Pharma Initiate P-ll Study of BNT162b2 Against COVID-19 in China

Shots: The companies initiated the P-II study of their COVID-19 vaccine in China. The trial will generate data to support the BLA filing for approval of the vaccine in China The study will be conducted by Jiangsu Provincial Center for Disease Control and Prevention. The study will commence with the recruitment of 960 patients aged …

BioNTech and Fosun Pharma Initiate P-ll Study of BNT162b2 Against COVID-19 in China Read More »

BioNTech, InstaDeep plan joint lab for AI research

BioNTech may be deeply ensconced in the latter stages of its bid to bring a COVID-19 vaccine to market, but it’s still pushing forward on other fronts, including a partnership with InstaDeep to deploy artificial intelligence and machine learning across its business. The two companies have been working together in this area since 2019, but …

BioNTech, InstaDeep plan joint lab for AI research Read More »

AstraZeneca, Oxford are latest to unveil Covid-10 vaccine results

The partners pooled results from two trials and two different dosing regimens, one appearing to be more effective than the other. They hope to produce 3 billion doses in 2021 with an emphasis on serving poorer countries.

AZ preps filings for COVID-19 jab, UK nears decision on Pfizer rival

AstraZeneca is preparing to file its COVID-19 vaccine with regulators after phase 3 trial results showed it is up to 90% effective. AZ made the announcement as the UK regulator reportedly gears up to make a decision on the rival vaccine from Pfizer and BioNTech, ahead of counterparts in the US and Europe. Results from …

AZ preps filings for COVID-19 jab, UK nears decision on Pfizer rival Read More »

PharmaShots Weekly Snapshot (Nov 16-20, 2020)

Eli Lilly and Incyte Receive FDA’s EUA for Baricitinib + Remdesivir to Treat Hospitalized Patients with COVID-19 Published: Nov 20,2020 | Tags: baricitinib, COVID-19, Eli Lilly, Emergency Use Authorization, FDA’s, Incyte, receives, Remdesivir Novartis Signs a License Agreement with Mesoblast to Develop and Commercialize Remestemcel-L for ARDS Published: Nov 20,2020 | Tags: Agreement, ARDS, Commercialize, …

PharmaShots Weekly Snapshot (Nov 16-20, 2020) Read More »

Pfizer/BioNTech prep US COVID-19 vaccine launch after emergency filing

Pfizer and BioNTech have filed for emergency use of their COVID-19 vaccine candidate in the US, paving the way for a launch before year-end. The announcement is no surprise as earlier this week, Pfizer’s CEO Albert Bourla said the company was preparing to file phase 3 data from the vaccine known as BNT162b2 with the …

Pfizer/BioNTech prep US COVID-19 vaccine launch after emergency filing Read More »

Pfizer and BioNTech’s BNT162b2 Demonstrates 95% Efficacy in Preventing COVID-19

Shots: The primary efficacy analysis demonstrated that BNT162b2 is 95% effective against COVID-19 beginning 28 days after the first dose. The study evaluated 170 confirmed cases of COVID-19 with 162 in PBO group vs 8 in the vaccine group The observed efficacy in adults over 65yrs. of age was ~94% and was well tolerated across …

Pfizer and BioNTech’s BNT162b2 Demonstrates 95% Efficacy in Preventing COVID-19 Read More »

Pfizer prepares to file COVID-19 shot after reaching safety milestone

Pfizer is preparing to file its COVID-19 vaccine after a trial reached the safety milestone required by US regulators for emergency use, according to press reports. The company’s CEO Albert Bourla said that the company is preparing to submit its data to the FDA following last week’s announcement that the vaccine is more than 90% …

Pfizer prepares to file COVID-19 shot after reaching safety milestone Read More »

Pfizer begins US pilot delivery programme for COVID-19 vaccine

Pfizer has begun a pilot delivery programme in the US for its experimental COVID-19 vaccine, as the company seeks to overcome logistical challenges caused by its ultra-cold storage requirements. The vaccine developed in partnership with Germany’s BioNTech has been shown to be 90% effective in clinical trials. But it has a major drawback in that …

Pfizer begins US pilot delivery programme for COVID-19 vaccine Read More »

PharmaShots Weekly Snapshots (Nov 09-13, 2020)

Qiagen Launches Portable Digital SARS-CoV-2 Antigen Test in the US Published: Nov 13,2020 | Tags: Antigen Test, Digital, Launches, Portable, Qiagen, SARS-CoV-2, US GSK and Medicago Initiate P-II/III Study of its Plant-Derived COVID-19 Vaccine Published: Nov 13,2020 | Tags: COVID-19, GSK, Initiate, Medicago, P-II/III, Plant- Derived study, vaccine BD Acquires the Medical Business Assets of …

PharmaShots Weekly Snapshots (Nov 09-13, 2020) Read More »

EU orders 300 million doses of BioNTech/Pfizer’s COVID-19 vaccine

The European Union has ordered 300 million doses of BioNTech/Pfizer’s COVID-19 vaccine following this week’s landmark announcement that it was effective in more than 90% of patients. The companies said deliveries of an initial order of 200 million vaccines will be subject to approval by European regulators and are expected to start by the end …

EU orders 300 million doses of BioNTech/Pfizer’s COVID-19 vaccine Read More »

Pfizer and BioNTech to Supply EU with up to 200M Doses of BNT162B2 Against COVID-19

Shots: The companies sign an agreement with the EC to supply 200M doses of BNT162b2 mRNA-based vaccine candidate against SARS-CoV-2 to EU member states, with an option to request an additional 100M doses Deliveries are anticipated to start by the end of 2020, following clinical success and regulatory authorization. The companies expect to produce ~1.3B …

Pfizer and BioNTech to Supply EU with up to 200M Doses of BNT162B2 Against COVID-19 Read More »

With 90% efficacy against Covid-19, Pfizer/BioNTech’s vaccine jumps ahead in global race

The news sent the stock market soaring as it represents a key milestone in developing and distributing a vaccine for the virus. Still public confidence in vaccines need to be boosted, an expert noted.

Pfizer/BioNTech say vaccine works in 90% of COVID-19 patients

As the death toll from COVID19 inexorably mounts, Pfizer and BioNTech have announced that their COVID-19 vaccine candidate is more than 90% effective at countering the disease in an interim analysis. The companies said they will be ready to file the vaccine with the FDA in the third week of November once they have enough …

Pfizer/BioNTech say vaccine works in 90% of COVID-19 patients Read More »

Moderna nears COVID-19 vaccine finish line as it wraps up study enrolment

Moderna is close to completing its phase 3 trial of COVID-19 vaccine candidate mRNA-1273 after completing recruitment of the 30,000 subjects in the trial. It’s also revealed that more than 25,000 of them have already received the second dose of the shot in the COVE study, putting it in contention to be the first coronavirus …

Moderna nears COVID-19 vaccine finish line as it wraps up study enrolment Read More »

Pfizer ‘ready to roll’ if BioNTech COVID-19 shot is approved

Pfizer now has hundreds of thousands of doses of BioNTech’s COVID-19 vaccine coming off the production line at a facility in Belgium, ready for delivery if it clears phase 3 testing. The output of the plant in Puurs should allow the partners to have 100 million doses of BNT162b2 ready for delivery by the end …

Pfizer ‘ready to roll’ if BioNTech COVID-19 shot is approved Read More »

UK government signs contract for COVID-19 challenge trial

The UK government has signed a contract to develop a controversial COVID-19 human challenge trial, where participants will be deliberately infected in a controlled environment with coronavirus to test whether a vaccine is effective. Contract research organisation (CRO) hVIVO, a subsidiary of Open Orphan, has signed the contract with the UK government to develop the …

UK government signs contract for COVID-19 challenge trial Read More »

Pfizer to wait until after election to file COVID-19 vaccine in US

Pfizer said it will wait until after the US election to file its COVID-19 vaccine with the US regulator, as it waits for important safety data to become available. The vaccine is being developed by Pfizer and development partner BioNTech and will wait until late November to make its application with the FDA. In a …

Pfizer to wait until after election to file COVID-19 vaccine in US Read More »

BioNTech and Pfizer Initiates Rolling Submission to EMA for SARS-CoV-2 Vaccine Candidate, BNT162b2

Shots: The Rolling Submission is based on the preliminary results from pre-clinical and early clinical studies in adults, which shows that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2. BioNTech and Pfizer plan to work with the EMA’s CHMP to complete the rolling review process …

BioNTech and Pfizer Initiates Rolling Submission to EMA for SARS-CoV-2 Vaccine Candidate, BNT162b2 Read More »

Race for COVID-19 vaccine hots up as EMA begins review of BioNTech/Pfizer jab

The European Medicines Agency has begun a second “rolling review” of a potential coronavirus vaccine jointly developed by BioNTech and Pfizer, setting up a race with a rival from AstraZeneca and Oxford University. The announcement comes just days after the regulator said its CHMP scientific committee had begun to look at the first batch of …

Race for COVID-19 vaccine hots up as EMA begins review of BioNTech/Pfizer jab Read More »

PharmaShots Weekly Snapshot (Aug 24 -28, 2020)

1. Taysha Gene Therapies’ TSHA-101 Receives the US FDA’s Orphan Drug Designation and Rare Pediatric Disease Designation for GM2 Gangliosidosis Published: Aug 27, 2020 | Tags:  Taysha Gene Therapies, TSHA-101, Receives, US, FDA, Orphan Drug Designation, Rare Pediatric Disease Designation, GM2 Gangliosidosis 2. Bayer Reports the NDA Submission to NMPA for Vericiguat to Treat Chronic …

PharmaShots Weekly Snapshot (Aug 24 -28, 2020) Read More »

BioNTech and Fosun Pharma to Supply ~10M Doses of COVID-19 Vaccine to Hong Kong and Macao

Shots: BioNTech and Fosun collaborated to supply 10M doses of their BNT162 mRNA-based vaccine candidate against COVID-19 to Hong Kong SAR and Macao SAR, once approved Fosun Pharma has signed the Letter of Intent with Jacobson for contemplated distribution of 10M doses of a vaccine targeting COVID-19 in the Chinese market On Mar 13, 2020, …

BioNTech and Fosun Pharma to Supply ~10M Doses of COVID-19 Vaccine to Hong Kong and Macao Read More »

Is COVID the Rx for the Pharmaceutical Industry’s Reputation?

Darlene Dobry, Strategic Advisor, Medical Devices and Pharmaceuticals As the COVID-19 pandemic continues to bring the world’s economies, healthcare systems, and communities to their knees, the Pharma industry appears to be the shining hope to help us return to a new normal. Could the industry’s response to this global public health crisis be the Rx …

Is COVID the Rx for the Pharmaceutical Industry’s Reputation? Read More »

PharmaShots Weekly Snapshot (Aug 17 -21 2020)

1. BioMarin Reports NDA Submission to the US FDA for Vosoritide to Treat Children with Achondroplasia Published: Aug 20, 2020 | Tags:  BioMarin, Reports, NDA, Submission, US, FDA, Vosoritide, Children, Achondroplasia 2. Junshi and Impact to Establish Joint Venture for Senaparib (IMP4297) in China Published: Aug 20, 2020 | Tags:  Junshi, Impact, Establish, Joint Venture, …

PharmaShots Weekly Snapshot (Aug 17 -21 2020) Read More »

Coronavirus pharma news round-up 21/08/20

New insights into smell and taste loss symptoms, artificial intelligence and further encouraging data from a vaccine candidate hit the headlines this week as the COVID-19 coronavirus pandemic continues. Here we highlight the biggest R&D, market access and digital coronavirus news of the past week. Pfizer and BioNTech have said their COVID-19 vaccine could be …

Coronavirus pharma news round-up 21/08/20 Read More »

Pfizer/BioNTech say COVID-19 jab on track for approval by year-end

Pfizer and BioNTech have said their COVID-19 vaccine could be ready for regulators to review by October and approved by the end of the year after releasing more favourable data from an early-stage trial. There are no vaccines approved for COVID-19 and governments across the world are striking deals with various manufacturers to get early …

Pfizer/BioNTech say COVID-19 jab on track for approval by year-end Read More »

Pfizer and BioNTech Plan for Regulatory Review of its COVID-19 Vaccine in October 2020

Shots: The companies have shared additional P-I safety and immunogenicity data from their ongoing US study of the BNT162b2 against SARS-CoV-2, which has advanced into P-II/III evaluation. Across all populations, BNT162b2 was well tolerated with mild to moderate fever in fewer than 20% of the participants In P-I study, BNT162b2 (@7days after the second dose …

Pfizer and BioNTech Plan for Regulatory Review of its COVID-19 Vaccine in October 2020 Read More »

BioNTech and Fosun Pharma Initiate Clinical Trial of BNT162b1 Against COVID-19 in China

Shots: The P-I study will evaluate the safety and immunogenicity of the vaccine as well as confirm dose selection in ~144 healthy subjects aged 18-55 and >55 yrs. As part of the two-dose cohort design, subjects will receive two injections (prime-boost), 21 days apart  BNT162b1 vs PBO The dose range was determined based on early …

BioNTech and Fosun Pharma Initiate Clinical Trial of BNT162b1 Against COVID-19 in China Read More »

Regeneron pairs with BioNTech on melanoma immunotherapy

Regeneron and Sanofi’s PD-1 inhibitor Libtayo will be tested in tandem with a cancer vaccine developed by BioNTech in melanoma in people who have failed treatment with other checkpoint inhibitors. The two companies will carry out a phase 2 trial of Libtayo (cemiplimab) alongside BioNTech’s mRNA cancer immunotherapy BNT111, which is designed to stimulate immune …

Regeneron pairs with BioNTech on melanoma immunotherapy Read More »

PharmaShots Weekly Snapshot (Jul 27- 31, 2020)

 1.  Oxford Biomedica Signs Three Year Clinical Supply Agreement with Axovant to Manufacture and Supply AXO-Lenti-PD for Parkinson’s Disease  Published: Jul 31, 2020 | Tags: Oxford Biomedica, Signs, Three Year, Clinical Supply Agreement, Axovant, Manufacture, Supply, AXO-Lenti-PD, Parkinson’s Disease 2.  Johnson & Johnson Initiates P-I/IIa Study of its Ad26.COV2.S Against COVID-19 in the US and Belgium …

PharmaShots Weekly Snapshot (Jul 27- 31, 2020) Read More »

Pfizer, BioNTech score deal to supply 120M Covid-19 vaccine doses to Japan

Financial terms of the deal were not disclosed, but it follows a $1.95 billion contract between the two companies and the U.S. government. Assuming clinical trial success and regulatory approval, they would supply the vaccines in early 2021, ahead of the rescheduled Tokyo Olympics.

Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – July 2020

Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected …

Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – July 2020 Read More »

Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19

Shots: The companies commence global (Ex- China) P-II/III study to evaluate a modRNA candidate (BNT162b2, 30µg dose level in a 2 dose regimen) from their BNT162 mRNA-based vaccine program against SARS-CoV-2 The P-II/III study follows the US FDA’s guidance on clinical trial design, will evaluate up to 30,000 participants in a ratio (1:1)  aged 18 …

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PharmaShots Weekly Snapshot (Jul 20- 24, 2020)

 1.  Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion for Moderate to Severe Rheumatoid Arthritis  Published: Jul 24, 2020 | Tags: Gilead, Galapagos, Jyseleca, filgotinib, Receive, CHMP, Positive Opinion,  Moderate, Severe, Rheumatoid Arthritis 2.  Synaffix Expands its Existing Collaboration with ADC Therapeutics to Explore Two Additional Programs Published: Jul 24, 2020 | Tags: Synaffix, Expands, …

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US places $1.95 billion order for Pfizer/BioNTech’s COVID-19 vaccine

The US government has agreed to pay Pfizer and BioNTech $1.95 billion to secure access to 100 million doses of their coronavirus vaccine on approval, just days after promising results in a clinical trial. The deal – part of the Trump administration’s Operation Warp Speed that aims to deliver 300 million coronavirus vaccines in early …

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Pfizer, BioNTech get $1.95B from HHS to supply Covid-19 vaccine

The companies will supply 100 million doses of the vaccine by the end of the year, and the government will have the option to acquire 500 million more. However, the FDA must grant an authorization based on its safety and efficacy, for which there are only preliminary data so far.

Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19

Shots: The companies reported that most advanced of four COVID-19 vaccine candidates from their BNT162 mRNA-based vaccine program demonstrated the ability to elicit high SARS-CoV-2 neutralizing titers following the second dose in an ongoing P-I/II study in Germany The results divulge that BNT162b1 candidate induced strong CD4+ and CD8+ T-cell responses. BNT162b1 elicits RBD-specific, interferon-g+, …

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UK announces COVID-19 vaccine deals with BioNTech/Pfizer and Valneva

The UK has secured 90 million doses of two different COVID-19 vaccines from BioNTech/Pfizer and Valneva, with an option of 40 million doses if they check out in trials.  There is no approved COVID-19 vaccine, but governments across the world are busy signing deals with developers to gain access should trial results check out.  The announcements came as the scientific community held …

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PharmaShots Weekly Snapshot (Jul 13- 17, 2020)

 1.  Eli Lilly Reports Results of Mirikizumab in P-III OASIS-2 Study to Treat Moderate to Severe Plaque Psoriasis Published: Jul 17, 2020 | Tags: Eli Lilly, Reports, Results, Mirikizumab, P-III, OASIS-2, Study, Treat, Moderate, Severe, Plaque Psoriasis 2.  Oncorus Initiates P-I Study of ONCR-177 in Patients with Advanced / Refractory Cutaneous Subcutaneous or Metastatic Nodal Solid …

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