Pharma

JPM22: Aftershocks for Lilly, CRISPR versus CRISPR and Bluebird's crucial year

A restrictive Medicare decision on Alzheimer's drugs sent Lilly shares tumbling, while the CEO of Editas brushed off competitive threats to his company's gene editing technology. 

By Ned Pagliarulo , Ben Fidler • Jan. 12, 2022

JPM22: M&A anxiety, Roche's comeback plan and Vir's omicron moment

Pharma executives fielded many questions about their dealmaking intentions on the conference's second day, while Roche outlined its plan to compete against Merck and Bristol Myers in cancer immunotherapy.

By Ben Fidler , Ned Pagliarulo • Jan. 11, 2022

Explore the Trendline➔

Inside the race to bring coronavirus vaccines to the world

More than a dozen shots are cleared for use in some fashion around the world. Producing enough supply and addressing the spread of coronavirus variants are the next challenges. 

By BioPharma Dive staff

Medicare proposes to limit coverage of Biogen Alzheimer's drug

The program will only cover Aduhelm, which the FDA controversially approved last June, for patients enrolled in rigorous clinical trials, likely forestalling broader adoption of the treatment.

By Jonathan Gardner , Jacob Bell • Updated Jan. 11, 2022

5 questions facing the FDA in 2022

If Robert Califf wins Senate confirmation as expected, he will face a lengthy agenda as well as questions on Aduhelm controversy, accelerated approval and agency funding.

By Jonathan Gardner • Jan. 11, 2022

JPM22: Pfizer's big bet on mRNA, Biogen 'proven wrong' on Aduhelm price and the next cell therapies

The healthcare conference's first day brought a trio of mRNA deals from Pfizer, a rare admission from Biogen's CEO and new focus on what's next in cell therapy.

By Ned Pagliarulo , Jonathan Gardner , Jacob Bell • Jan. 10, 2022

The pandemic isn't over; neither is the new era of healthcare logistics

We have to focus on maintaining a sustainable, collaborative supply chain that delivers for everyone on this hard road ahead.

Jan. 10, 2022

US pauses distribution of Regeneron, Lilly antibodies over omicron concerns

The decision follows worrisome results in lab studies that indicated omicron can evade both drugs and leaves the U.S. with fewer treatments to respond to the variant's spread.

By Ben Fidler • Updated Jan. 4, 2022

Novartis wins FDA approval for new heart drug, but faces uphill sales battle

Leqvio, which Novartis acquired for nearly $10 billion two years ago, arrives with high sales expectations. But uptake could be slow as insurers and doctors weigh the drug's safety and cost-effectiveness.

By Jonathan Gardner • Dec. 22, 2021

COVID-19 pills from Pfizer, Merck authorized by FDA in major pandemic milestone

Paxlovid and molnupiravir are the first oral treatments for COVID-19, potentially valuable new tools as the fast-spreading omicron variant fuels a sharp surge in cases across the U.S. 

By Jonathan Gardner • Updated Dec. 23, 2021

Novartis ups investment in gene therapy for the eye with $800M buyout

The deal for Gyroscope Therapeutics, worth up to $1.5 billion, gives the Swiss pharma access to a treatment for a type of age-related blindness as well as new means of delivering drugs into the eye.

By Jonathan Gardner • Dec. 22, 2021

Duchenne patient dies in Pfizer gene therapy study

The tragic news follows changes Pfizer recently made to the design of another study testing the therapy due to side effects seen in some participants. 

By Jonathan Gardner • Dec. 21, 2021

GSK's long-acting HIV shot approved for preventive use

The landmark FDA approval makes Apretude the first injectable treatment in the U.S. for HIV pre-exposure prophylaxis.

By Jacob Bell • Dec. 21, 2021

Sanofi to buy cancer immunotherapy biotech for $1B

The French drugmaker is interested in Amunix Pharmaceuticals' technology, which could allow for more precise delivery of biologic drugs into cancerous tissue.

By Ned Pagliarulo • Dec. 21, 2021

EU regulator says member countries can use Pfizer's experimental COVID pill

The European Medicines Agency is still reviewing Paxlovid but, citing fast increasing cases and deaths from COVID-19, offered flexibility to EU countries which may authorize emergency use.

By Ned Pagliarulo • Dec. 16, 2021

Flush with cash, large drugmakers turn to share buybacks, deals

Novartis is using funds gained from the recent sale of its stake in Roche to buy back $15 billion worth of its own shares, while Pfizer is signaling more dealmaking could follow its buyout of Arena.

By Ned Pagliarulo • Dec. 16, 2021

Pfizer opens gene therapy plant in $800M North Carolina expansion

The new facility cost nearly $70 million to build, and is part of a major push by the pharma giant to become a leader in genetic medicine manufacturing.

By Kristin Jensen • Dec. 16, 2021

Lilly ups revenue forecast amid windfall from COVID-19 drugs

While the boost from its COVID-19 treatments might be temporary, Lilly believes next year's revenue will hold up thanks to newer products. Also on the horizon are potential approvals for key Alzheimer's and diabetes medicines.

By Jacob Bell • Dec. 15, 2021

Bristol Myers returns to Immatics for a dual-targeting cancer drug

The pharma has expanded an alliance with a German biotech by paying $150 million for a drug candidate that executives hope can have "cell therapy-like efficacy" for solid tumors. 

By Ben Fidler • Dec. 14, 2021

Latest Roche results show promise for new type of cancer immunotherapy

Updated Phase 2 data suggested an experimental drug targeting the protein TIGIT could bolster the benefit of Roche's Tecentriq in certain people with advanced lung cancer.

By Ben Fidler • Dec. 10, 2021

AstraZeneca antibody cleared by FDA for preventive use against COVID-19

Evusheld, a combination of two antibodies, is meant to be long-acting, proving protective against disease through six months in clinical testing.

By Ned Pagliarulo • Dec. 8, 2021

Vaccine from Medicago, GSK protective against COVID-19 in large study

The vaccine, which Medicago plans to soon submit to Canadian regulators, would be the first of its type, though supply appears likely to be limited.

By Jonathan Gardner • Dec. 7, 2021

Lilly drug becomes first COVID antibody cleared for use in young children

The emergency clearance from the FDA allows for treatment of mild and moderate disease as well as prevention in those exposed and at high risk.

By Jonathan Gardner • Dec. 6, 2021

Novartis pays $150M for access to UCB's Parkinson's drug

UCB's experimental pill is one of the most advanced projects that's aimed at blocking accumulation of an abnormal protein in patients' brains.

By Jonathan Gardner • Dec. 2, 2021

FDA panel, after debate, narrowly backs Merck COVID pill

While agency advisers raised concerns over molnupiravir's modest benefits and potential risks, a majority felt the antiviral drug is a needed option for COVID-19 patients at high risk of severe disease.

By Jonathan Gardner • Updated Nov. 30, 2021

GSK hires away top Pfizer vaccine scientist

Philip Dormitzer, who helped Pfizer develop shots for COVID-19, RSV and influenza, will become the British pharma's head of vaccine R&D next month.

By Ned Pagliarulo • Nov. 30, 2021