Pfizer

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

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Experts say the development of blood clots after getting the jab is still an ‘exceedingly rare’ side effect. So what triggered the government’s change in position? Australia’s vaccine rollout is facing a major shake-up after the federal government heeded the advice of its independent health… Read More »What does Australia’s new advice on the AstraZeneca Covid vaccine mean and what is the risk?

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

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

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

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Shots: The approval is based on P-III CROWN study assessing Lorbrena vs Xalkori (crizotinib) monthx in 296 people in a ratio (1:1) with prior untreated advanced ALK-positive NSCLC The P-III study resulted in a 72% reduction in risk of progression or death as assessed by… Read More »Pfizer’s Lorbrena (lorlatinib) Receives FDA’s Approval for Expanding its Indication to Treat ALK-Positive Metastatic Lung Cancer

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

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Shots: The US FDA has accepted the PR of BLA for TicoVac to prevent TBE in patients aged ≥1year with an anticipated PDUFA date in Aug 2021. If approved, the vaccine may help reduce the risk of TBE for people traveling to endemic areas The… Read More »Pfizer Reports the US FDA’s Acceptance and Priority Review of BLA for Ticovac (Tick-Borne Encephalitis Vaccine)

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

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

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

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Shots: The approval is based on the P-III study that involves assessing Panzyga (IVIg) in 142 patients with CIDP. The study evaluated more than one maintenance dosing option while the efficacy, safety, and tolerability were observed during 7 maintenance infusions @3wks. intervals over a 6mos.… Read More »Pfizer’s Panzyga Receives the US FDA’s Approval of sBLA for Chronic Inflammatory Demyelinating Polyneuropathy

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

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Shots: Imcyse to receive up front, ~$180M as milestones along with royalties. Pfizer to purchase an equity stake in Imcyse Initially, the companies will collaborate to develop existing lead candidates and further optimize potential molecules. Later, Pfizer will lead clinical development and commercialization activities for… Read More »Pfizer Signs a License and Research Agreement with Imcyse to Develop Imotopes for Rheumatoid Arthritis

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

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Shots: The post marketing Oral Surveillance involves assessing the safety of tofacitinib at two doses (5 mg, bid and 10mg, bid) vs TNFi in 4362 patients in subjects with RA aged ≥ 50yrs. and had at least one additional CV risk factor The primary analyses… Read More »Pfizer’s Xeljanz (tofacitinib) Fails to Meet its Co-Primary Endpoint in ORAL Surveillance Safety Study

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

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Hot on the heels, Aurinia launches its drug in the Lupus market after GSK Aurinia Pharmaceuticals has recently got the USFDA approval for its Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active Lupus nephritis (LN). Lupkynis is… Read More »Aurinia’s Lupkynis for Lupus; FDA Fast Track Designation for Toripalimab; Wren Therapeutics’ Financing; Merck’s Covid-19 Vaccine Program End

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

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Nations outbidding each other creates an ‘immoral race towards the abyss’ Coronavirus – latest updates See all our coronavirus coverage Pharmaceutical companies should do more to transfer vaccine technology to prevent the poorest countries falling behind in the distribution of Covid-19 vaccines, according to an… Read More »World’s poor need action, not Covid ‘vaccine nationalism’, say experts

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

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Surge in infections dampens optimism over country’s advanced immunisation programme Coronavirus – latest updates See all our coronavirus coverage Israel’s coronavirus tsar has warned that a single dose of the Pfizer/BioNtech vaccine may be providing less protection than originally hoped, as the country reported a… Read More »Single Covid vaccine dose in Israel ‘less effective than we hoped’

PharmaShots Weekly Snapshots (Jan 11 – 15, 2021)

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Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria Published: Jan 15, 2020 | Tags: Novartis’, Ligelizumab (QGE031), Receives ,US FDA’s, Breakthrough Designation for Patients , Chronic Spontaneous Urticaria Philips Collaborates with Merck KGaA to Advance Personalized Fertility Treatment… Read More »PharmaShots Weekly Snapshots (Jan 11 – 15, 2021)

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

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Shots: The approval is based on the ADVL0912 study assessing Xalkori in 121 patients aged 1-21yrs. that included 26 patients with r/r, systemic ALK+ ALCL prior treated with at least one systemic treatment The study showed 88% ORR. Among 23 patients, who achieved a response,… Read More »Pfizer’s Xalkori (crizotinib) Receives the US FDA’s Approval for ALK-Positive Anaplastic Large Cell Lymphoma In Children And Young Adult

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

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Shots: ImaginAb to receive license fees and payments for manufacturing and other support and will supply clinical doses of 89Zr CD8 Immuno-PET agent to Pfizer for use in select oncology clinical trials ImaginAb will provide technical, clinical & regulatory support to Pfizer The collaboration follows… Read More »Pfizer Signs a License and Supply Agreement with ImaginAb for CD8 ImmunoPET Technology

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

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Shots: Dewpoint to receive up front payment and up to $239M as research, development & commercial milestones along with royalties on sales of the therapies The companies collaborated for the development of therapies to treat DM1 The companies will collaborate their expertise to advance the… Read More »Pfizer Collaborates with Dewpoint to Develop Therapies for Rare Form of Muscular Dystrophy

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

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Pfizer and OPKO Health: A step closer to FDA Nod for pediatric growth hormone deficiency (GHD) drug, Somatrogon Pfizer and Opko had joined hands in 2014 to develop somatrogon, a pediatric growth hormone deficiency (GHD) drug. It comprises the natural sequence of growth hormone and… Read More »Pfizer/ OPKO Health’s Somatrogon; FDA EU for SCONE device; Antengene ATG-010 for rrMM and rrDLBCL; SanBio STEMTRA Phase 2 Interim Results

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

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Shots: The BLA submission is based on P-lll study assessing the safety and efficacy of Somatrogon (0.66 mg/kg, qw) vs Somatropin (0.034 mg/kg, qd) in 224 pediatric patients in the ratio of (1:1) with GHD The study met its 1EPs of non-inferiority as measured by… Read More »Pfizer and OPKO Reports the US FDA’s Acceptance of BLA for Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency

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

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Rehovot Science Park What You Should Know: – Pfizer, AstraZeneca, Merck, and Teva, and Amazon Web Services (AWS) has been selected by the Israel Innovation Authority to establish an innovation lab in the fields of digital health and computational biology. – The innovation lab located… Read More »Amazon, AstraZeneca, Pfizer, Merck to Build $10M Digital Health Innovation Lab in Israel

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

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Shots: The US FDA has accepted for Priority Review the sNDA is based on the pivotal CROWN study and is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) CROWN is P-lll, parallel 2-arm trial in which 296 previously untreated advanced ALK-positive NSCLC… Read More »Pfizer Report the US FDA’s Acceptance and Priority Review of sNDA for Lorbrena (lorlatinib) to treat (ALK)-Positive (NSCLC)

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

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Shots: Myovant & Pfizer will jointly develop & commercialize ORGOVYX (relugolix) in advanced prostate cancer & if approved, relugolix combination tablet in women’s health in the US & Canada. Myovant will receive ~$4.2B including $650M upfront, $200M in regulatory milestones for FDA approvals for relugolix… Read More »Myovant Signs Agreement with Pfizer to Develop and Commercialize Relugolix in Oncology and Women’s Health

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

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A USD 4.2 Billion Myovant/ Pfizer Deal Myovant Sciences have decided to put their forces and efforts together to advance the Prostate cancer market as they announced their partnership deal to develop and market relugolix for prostate cancer and women’s health.  Relugolix is a once-daily,… Read More »A USD 4.2 Billion Myovant/ Pfizer Deal; Audentes Therapeutics’ ASPIRO Trial Free to Proceed; First Generic of Drug for Severe Hypoglycemia Gets Approval; Teleflex Acquires Z-Medica

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

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What You Should Know: – The American Medical Association (AMA) announced the addition of three Current Procedural Terminology (CPT) codes for AstraZeneca’s COVID-19 vaccine. The American Medical Association (AMA) today announced that the Current Procedural Terminology (CPT®) code set is being updated by the CPT Editorial Panel… Read More »AMA Adds 3 Additional CPT Codes for AstraZeneca’s COVID-19 Vaccine

INVEST Precision Medicine Pitch Perfect winner spotlight: TrialSpark

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

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

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

FDA gives nod to Moderna vaccine for Covid-19

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

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

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Pharmaceutical companies complain of breach of confidentiality after amount EU has agreed to pay for leading vaccines goes public Coronavirus – latest updates See all our coronavirus coverage A Belgian minister has inadvertently blown the lid off a sensitive and commercial secret – the price… Read More »Belgian minister tweets EU’s Covid vaccine price list to anger of manufacturers

FTA for Gannex’s ASC4; Disappointment for Incyte’s Ruxolitinib; Historic win for Pfizer, BioNTech’s COVID Vaccine; Alexion buyout; the debut of InnoSkel

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Gannex received US FDA fast track designation for its NASH drug, ASC42 an FXR Agonist Gannex Pharma has received Fast Track designation approval from FDA for its drug candidate ASC42 for non-alcoholic steatohepatitis (NASH). The FTA designation will help the pharma company to advance its… Read More »FTA for Gannex’s ASC4; Disappointment for Incyte’s Ruxolitinib; Historic win for Pfizer, BioNTech’s COVID Vaccine; Alexion buyout; the debut of InnoSkel

FDA gives emergency OK to Pfizer and BioNTech vaccine

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The vaccine was developed in record time, a big scientific accomplishment, even though the agency’s move follows an unusual level of pressure from President Trump’s White House, renewing concerns that politics drove the vaccine process even as the first doses are shipped.

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

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

NHS told not to give Pfizer vaccine to extreme allergy sufferers after two people have reaction

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Anyone scheduled to receive vaccine will be asked about history of allergic reactions Coronavirus – latest updates See all our coronavirus coverage Regulators have issued a warning that people who have a history of “significant” allergic reactions should not currently receive the Pfizer/BioNTech Covid-19 vaccine… Read More »NHS told not to give Pfizer vaccine to extreme allergy sufferers after two people have reaction

A history of Pfizer

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Few companies embody the term ‘pharma giant’ as much as Pfizer. Here we take a look at the colourful history of one of the biggest drugmakers in the world. Pfizer was founded in 1849 by two recent German immigrants to the USA, Charles Pfizer and… Read More »A history of Pfizer

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

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

BioNTech’s Covid vaccine is a triumph of innovation and immigration | Hans-Werner Sinn

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Pioneered by a Turkish-German couple, its significance exceeds its practical value The world took note when the German startup BioNTech announced its breakthrough in the development of a new type of vaccine to combat Covid-19. After testing tens of thousands of people, BioNTech’s vaccine has… Read More »BioNTech’s Covid vaccine is a triumph of innovation and immigration | Hans-Werner Sinn

A vaccine revolution | podcast

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Results from clinical trials have shown that the world has three apparently highly effective vaccines for Covid-19. With the race now on for regulatory approval, production and distribution, is the end of the pandemic within reach? After a gruelling year of successive waves of Covid-19… Read More »A vaccine revolution | podcast

The Guardian view on coronavirus and vaccine scepticism: time to act | Editorial

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Plans for mass immunisation against Covid-19 are developing fast, but concerns must be addressed In the 1960s, academics studying rumours drew inspiration from epidemiology. They noted how such stories spread through communities, “infecting” some individuals while others seemed immune, and how more resistant populations could… Read More »The Guardian view on coronavirus and vaccine scepticism: time to act | Editorial

Pfizer Launches US Pilot Programme for Delivery and Distribution of COVID-19 Vaccine, BNT162b2

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Shots: Pfizer launched a pilot program to support the state’s planning, deployment & administration of the COVID-19 vaccine candidate, to build on coordination with the relevant US agencies Pfizer has been working with US officials in OWS & the US CDC to help ensure that… Read More »Pfizer Launches US Pilot Programme for Delivery and Distribution of COVID-19 Vaccine, BNT162b2

Easier distribution may make Moderna’s vaccine much more valuable | Nils Pratley

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While Pfizer/BioNTech’s version requires -75C storage, Moderna’s could be easier to roll out A second coronavirus vaccine candidate was always likely to struggle to match the excitement of the first, at least in stock market terms. Sure enough, Moderna’s promising trial results merely added to… Read More »Easier distribution may make Moderna’s vaccine much more valuable | Nils Pratley

It’s the ‘vaccine hesitant’, not anti-vaxxers, who are troubling public health experts | Gaby Hinsliff

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To make vaccination work, we must reach out to the naturally cautious – a bigger proportion than you might assume Coronavirus – latest updates See all our coronavirus coverage Lydia Guthrie is not very daring by nature. A psychotherapist and mother of two from Oxford,… Read More »It’s the ‘vaccine hesitant’, not anti-vaxxers, who are troubling public health experts | Gaby Hinsliff

The Covid vaccine will benefit humanity – we should all own the patent | Owen Jones

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The pharmaceutical industry has long made exorbitant profits by free-riding on research carried out by the public sector Hooray for Pfizer! As news of a vaccine potentially offering 90% protection against Covid-19 offers a life raft for lockdown-weary humanity, perhaps those home-drawn posters on people’s… Read More »The Covid vaccine will benefit humanity – we should all own the patent | Owen Jones

Why a Covid vaccine doesn’t mean the end of face masks yet | David Salisbury

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Despite the Pfizer breakthrough, social distancing and remote working won’t disappear overnight Coronavirus – latest updates See all our coronavirus coverage The news this week that the Pfizer/BioNTech vaccine protected more than 90% of recipients is of huge importance. The vaccine efficacy is higher than… Read More »Why a Covid vaccine doesn’t mean the end of face masks yet | David Salisbury

Pfizer Reports Results of Abrocitinib in Fifth P-lll JADE REGIMEN Across Different Dosing Regimens

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Shots: The P-lll JADE REGIMEN study involves assessing of Abrocitinib (100/ 200mg) vs PBO in 1233 patients aged ≥ 12 yrs. in a ratio (1:1:1) with mod. to sev. AD following response to initial open-label induction treatment with abrocitinib (200mg) Result: The study met its… Read More »Pfizer Reports Results of Abrocitinib in Fifth P-lll JADE REGIMEN Across Different Dosing Regimens

Where will poorer countries stand in the queue for a Covid-19 vaccine? | Clare Wenham and Mark Eccleston-Turner

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The lion’s share of the potential Pfizer vaccine is already claimed by high-income nations The news that joint efforts by the US pharmaceutical company Pfizer and the German biotech company BioNtech have produced a vaccine that is 90% effective at protecting people from Covid-19 has… Read More »Where will poorer countries stand in the queue for a Covid-19 vaccine? | Clare Wenham and Mark Eccleston-Turner

Important questions about Pfizer’s Covid-19 vaccine

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News of positive results from Pfizer’s Covid-19 vaccine is heartening but historically, important scientific announcements about vaccines are made through peer-reviewed medical research papers that have undergone extensive scrutiny about study design, results and assumptions, not through company press releases.

Despite the fine print, we can still feel optimistic about a Covid vaccine | Charlotte Summers

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Pfizer’s preliminary results are a huge development, although hurdles still lie ahead Dr Charlotte Summers is a lecturer in intensive care medicine at the University of Cambridge Coronavirus – latest updates We could all do with some good news right now. After a long and… Read More »Despite the fine print, we can still feel optimistic about a Covid vaccine | Charlotte Summers

Exact Sciences and Pfizer Announce Extension and Amendment of their Cologuard Promotion Agreement

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Shots: Pfizer will continue to provide sales and marketing support and health system support for Cologuard through the end of 2022 and 2021, respectively. Exact Sciences will compensate Pfizer based on the amount of services provided, along with additional fixed and performance-related fees set forth… Read More »Exact Sciences and Pfizer Announce Extension and Amendment of their Cologuard Promotion Agreement

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

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

Pfizer Signs an Agreement with SpringWorks to Evaluate Nirogacestat + PF‐06863135 for R/R Multiple Myeloma

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Shots:   Pfizer to sponsor & conduct P-Ib/II study evaluating the safety, tolerability, and preliminary efficacy of dual regimen and will assume costs of study & other expenses related to IP rights.  The companies will form a joint development committee to manage clinical study which is… Read More »Pfizer Signs an Agreement with SpringWorks to Evaluate Nirogacestat + PF‐06863135 for R/R Multiple Myeloma

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

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

Pfizer, BioNTech start late-stage study of Covid-19 vaccine

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The companies said they had started a Phase II/III trial BNT162b2. The news comes the day after Moderna announced the launch of its Phase III study and days after Pfizer and BioNTech signed a nearly $2 billion vaccine supply deal with the federal government.