A Pfizer gene therapy for Duchenne muscular dystrophy failed its Phase 3 clinical trial. But analysts draw distinctions between that therapy and Sarepta Therapeutics’ Elevidys, which awaits an FDA decision that could grant it full regulatory approval.

The post Pfizer & Sarepta Gene Therapies Both Failed Phase 3, But Analysts Expect Sarepta Will Win Approval appeared first on MedCity News.

The FDA has approved Beqvez, a Pfizer gene therapy developed for moderate-to-severe hemophilia B. The one-time treatment carries a $3.5 million price tag, the same as a CSL Behring gene therapy already available for treating the inherited bleeding disorder.

The post Pfizer’s First Gene Therapy Approval Sets Up a Showdown With CSL in Hemophilia B appeared first on MedCity News.

The former Pfizer statistician worked on the clinical trial for the Covid-19 drug Paxlovid. A jury found the employee guilty of insider trading for transactions made before clinical data for the antiviral were publicly announced.

The post Ex-Pfizer Employee Convicted for Insider Trades Ahead of Positive Paxlovid Data appeared first on MedCity News.

BridgeBio will receive $500 million in exchange for royalties from sales of acoramidis, a drug currently under FDA review for treating heart complications caused by the rare disease transthyretin amyloidosis. The deal also refinances lending agreements, providing BridgeBio with access to additional capital.

The post Gearing Up to Challenge Pfizer in a Rare Disease, BridgeBio Secures Up to $1.25B appeared first on MedCity News.

Pfizer already reported its experimental drug for hemophilia A and B met a pivotal study’s goals of reducing bleeding episodes. During the annual meeting of the American Society of Hematology, the company presented a full look at the results, which are expected to support regulatory submissions soon.

The post On Heels of ASH Data, Pfizer Eyes FDA Submission for New Hemophilia Drug appeared first on MedCity News.

SpringWorks Therapeutics drug Ogsiveo is now FDA-approved for treating desmoid tumors, a type of tumor affecting connective tissue. The regulatory decision makes the pill the first therapy approved specifically for treating this rare disorder.

The post FDA Approval of SpringWorks Drug Is the First for Rare Connective Tissue Tumor appeared first on MedCity News.

The FDA approved Pfizer’s Penbraya for vaccinating against five bacterial groups that can cause meningococcal disease. Pfizer already has vaccines covering those groups, but Penbraya addresses all of them in a single vaccine, making dosing easier for patients.

The post Pfizer Meningococcal Vaccine Nabs FDA Nod, Offering More Convenient Dosing appeared first on MedCity News.

Pfizer lowered its revenue projections for 2023, a change it attributed to declining demand for its Covid-19 vaccine, Comirnaty, and antiviral drug, Paxlovid. Citing this revenue decline, Pfizer is implementing a companywide cost-cutting plan projected to save $3.5 billion.

The post Pfizer Shaves Revenue Projections, Starts Cost-Cutting Plan Amid Lower Covid-19 Product Demand appeared first on MedCity News.

Pfizer’s new FDA-approved ulcerative colitis drug Velsipity comes from its $6.7 billion Arena Pharmaceuticals acquisition. The small molecule will compete against blockbuster Bristol Myers Squibb drug Zeposia, which addresses the same target.

The post Pfizer Expands in Immunology With FDA Approval of New Ulcerative Colitis Drug appeared first on MedCity News.

The FDA said the updated messenger RNA vaccines from Pfizer/BioNTech and Moderna will protect against the omicron subvariants now prevalent in circulation. Left out of the FDA decision is Novavax, whose protein-based vaccine is still under regulatory review.

The post FDA Approves Updated Covid-19 Vaccines to Address Now Circulating Variants appeared first on MedCity News.

Oncology is already a big piece of Pfizer’s drug lineup. The portfolio is expanding to multiple myeloma with FDA approval of Elrexfio, a bispecific antibody that targets the cancer protein BCMA.

The post Pfizer Expands to Multiple Myeloma With FDA Approval for New Antibody Drug appeared first on MedCity News.

GSK claims that Pfizer’s FDA-approved vaccine for respiratory syncytial virus infringes on four patents protecting its own approved vaccine, Arexvy. The patent suit comes with the RSV season approaching.

The post GSK Patent Suit Aims to Halt Pfizer’s RSV Vaccine for Adults, But Not Infants appeared first on MedCity News.

Pfizer and Flagship Pioneering are partnering in a drug research alliance leveraging the capabilities of the more than 40 biotech startups in the venture capital firm’s portfolio. The new partners aim to develop drugs for unmet needs, including those in broad patient populations.

The post Pfizer, Flagship Team Up in $100M R&D Pact: 10 New Drugs for Unmet Needs appeared first on MedCity News.

Ngenla, a hormone drug from partners Pfizer and Opko Health, is now FDA approved for treating children with growth hormone deficiency. The once-weekly injectable biologic will compete against an Ascendis Pharma product that won its FDA approval in 2021.

The post Pfizer Growth Hormone Drug Measures Up at FDA With O.K. for Weekly Dosing appeared first on MedCity News.

Pfizer’s Litfulo is the first treatment approved for treating adolescents with severe alopecia areata. The drug’s approval also covers adults, were it will compete against Eli Lilly’s Olumiant.

The post FDA Approval of Pfizer Alopecia Drug Brings New Competition to Eli Lilly Med appeared first on MedCity News.

Pfizer’s Abrysvo is now approved for preventing illness caused by respiratory syncytial virus, or RSV, in adults 60 and older. The regulatory decision comes weeks after GSK won approval for its RSV vaccine, Arexvy.

The post Pfizer’s RSV Vaccine Wins FDA Approval on Heels of Regulatory Nod for GSK appeared first on MedCity News.

Marstacimab, a Pfizer drug for both hemophilia A and B, met the main goal of a Phase 3 study and the company now plans to discuss the data with regulators. The Pfizer drug could beat to the market a Novo Nordisk drug that addresses the same novel target.

The post Pfizer Hemophilia Drug Reduces Bleeding in Key Study; Regulatory Filings Are Planned appeared first on MedCity News.

Paxlovid, a Pfizer antiviral awarded FDA emergency authorization in 2021 for treating Covid-19, is now approved for treating adults. Results from a pivotal clinical trial showed that Paxlovid led to an 86% reduction in Covid-19-related hospitalization or death from any cause compared to a placebo.

The post FDA Nod Makes Pfizer’s Paxlovid the First Approved Oral Covid-19 Antiviral Drug appeared first on MedCity News.

The FDA will decide this summer which strains the next Covid-19 vaccines should address. But companies are also taking a longer view, developing shots for the future that offer different features than the current ones and potentially broader protection against a wider range of pathogens.

The post The Public Health Emergency Is Expiring, So What Is the Future of Covid-19 Vaccines? appeared first on MedCity News.

Older adults and immunocompromised people may now get a second Covid-19 booster shot, according to amendments to the FDA authorizations of the mRNA vaccines. Further changes will be discussed at an advisory committee meeting planned for June.

The post FDA’s Covid-19 Changes Set Stage for the Vaccines to Emulate Seasonal Flu Shots appeared first on MedCity News.

Royalty Pharma’s milestone payment from the approval of Pfizer migraine drug Zavzpret stems from financing deals struck with the therapy’s previous developer, Biohaven Pharmaceuticals. Royalty Pharma is also in line to receive royalty payments going beyond the next decade.

The post Pfizer’s Migraine Drug Approval Triggers $475M Payment to Royalty Pharma appeared first on MedCity News.

Pfizer is no stranger to antibody drug conjugate cancer therapies, but it hasn’t been commercially successful with them. The pharma giant’s agreement to acquire Seagen for $43 billion will thrust it to the forefront of the ADC drug class, which has become a hot space for research and regulatory activity in recent years.

The post Pfizer’s Seagen Acquisition Brings It Full Circle in a Hot Area of Cancer Drug R&D appeared first on MedCity News.

Pfizer’s respiratory syncytial virus vaccine candidate infants has clinical data showing it helped prevent severe infections in infants. It’s a maternal vaccine that produces antibodies in the mother that confer temporary protection to a baby.

The post Pfizer RSV Vaccine Hits Trial Goal for Infants; Year-End FDA Filing Planned appeared first on MedCity News.

The FDA has authorized mRNA Covid-19 booster shots designed to protect against the original strain of the novel coronavirus, as well as the two omicron subvariants that are currently driving U.S. caseloads. An advisory committee to the CDC is scheduled to discuss these vaccines and vote on their recommended use on Thursday.

The post FDA authorizes updated Covid-19 boosters to protect against omicron this fall, winter appeared first on MedCity News.

Moderna is suing Pfizer and BioNTech, claiming they copied its messenger RNA work in developing their Covid-19 vaccine. The company notes that its patented work in respiratory infectious disease began years before the start of the Covid-19 pandemic, when the biotech was pursuing an mRNA vaccine for a different coronavirus.

The post Moderna’s Covid-19 vaccine patent suit points to different virus to make infringement case against Pfizer appeared first on MedCity News.

Pfizer and BioNTech have completed their filing seeking FDA emergency use authorization of their omicron-adapted Covid-19 booster shot. Production of this bivalent vaccine has already begun, enabling the companies to begin distribution as soon as the FDA authorizes the shot.

The post Pfizer, BioNTech seek FDA authorization for omicron-adjusted Covid-19 boosters appeared first on MedCity News.

Pfizer’s own R&D efforts in sickle cell disease have fallen short, so the pharmaceutical giant is turning to M&A to gain a presence in the blood disorder. The acquisition of Global Blood therapeutics brings the commercialized drug Oxbryta plus a pipeline of other therapeutic candidates.

The post Pfizer to buy sickle cell disease biotech Global Blood Therapeutics in $5.4B deal appeared first on MedCity News.

Pfizer is stopping work on a drug for a rare heart disease after an interim look at Phase 3 data indicated that the study was unlikely to succeed. The small molecule came to Pfizer’s drug pipeline as part of the $11.4 billion acquisition of Array Biopharma in 2019.

The post Disappointing data lead Pfizer to drop heart drug acquired as part of $11B deal appeared first on MedCity News.

A panel discussion on the future of digital medicine highlighted some of the collaborations taking place between pharma companies and digital health, as well as some of the challenges facing the push towards mainstream implementation.

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The conference highlights the convergence of digital health and drug development. Among the panel discussions are a focus on the state of AI in drug discovery and the future of digital medicines. A startup pitch contest spotlights companies seeking to improve clinical trials. Register for free today!

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