Lilly looks to speed FDA review of new diabetes drug in obesity

A new fast track designation allows Lilly to begin the process of seeking approval of tirzepatide for obesity, though the drug will need to succeed in a second trial to get to market.  

By Jonathan Gardner • Oct. 6, 2022

Biogen to pay $900M to settle lawsuit over MS drug outreach

A former Biogen employee sued in 2012, alleging the company paid physician fees to encourage prescribing of its drugs. Biogen did not admit wrongdoing as part of the settlement.

By Christopher Newman • Sept. 27, 2022

Explore the Trendline➔

Commercialization

New drugs for obesity and Alzheimer’s look set to become blockbusters, reshaping pharma marketing strategies just as many current top-sellers near looming patent cliffs.

By BioPharma Dive staff

Optimizing pharmaceutical innovation

Elevate pharma product development and marketing through collaboration with physician experts

Sept. 19, 2022

Sanofi, AstraZeneca secure EMA support for RSV drug in babies

If authorized by the European Commission, the companies’ antibody medicine would become the first cleared for broad use in newborns and infants. 

By Jonathan Gardner • Sept. 16, 2022

Bristol Myers gets FDA approval for new type of psoriasis drug

Sotyktu has been on the pharma’s top pipeline candidates and its clearance continues a string of positive regulatory news for the company.

By Jonathan Gardner • Updated Sept. 12, 2022

FDA names new head to vaccine review office

David Kaslow, the lead scientist at a global public health nonprofit, will succeed Marion Gruber, who retired last fall amid her dissent on the timing of COVID-19 vaccine boosters.

By Jonathan Gardner • Sept. 9, 2022

FDA holds back Alvotech’s Humira biosimilar over manufacturing issues

The company received a complete response letter, but still expects to win approval of the copycat drug in time to launch it in the U.S. next year.

By Jonathan Gardner • Sept. 6, 2022

Funds for free COVID-19 vaccines could run out as early as January, HHS says

The commercial market for COVID-19 vaccinations could be similar to that for seasonal flu shots and other vaccines, an official with the department said.

By Sydney Halleman • Aug. 31, 2022

Incyte secures second approval for targeted cancer drug

Sold as Pemazyre, the drug, which blocks well-known cancer proteins known as FGFRs, is now also cleared for use in certain patients with very rare and aggressive blood cancers.

By Jacob Bell • Aug. 29, 2022

Psychedelic clinical trials: What sponsors should know when designing new protocols

With regulators and lawmakers seemingly on board, sponsors have more opportunities than ever to pursue clinical research in this high-velocity area.

Aug. 29, 2022

Moderna sues Pfizer, BioNTech over COVID-19 vaccine technology

The biotech claims its rivals’ vaccine Comirnaty, one of the world’s top-selling pharmaceutical products, infringes on two patents covering its messenger RNA technology.

By Jonathan Gardner • Aug. 26, 2022

Novartis begins plans to spin off generic drug business

After reviewing multiple options including a possible sale, the Swiss drugmaker said spinning off Sandoz would give the division “greater freedom to operate” and capitalize on newly growing sales.

By Jonathan Gardner • Aug. 25, 2022

Gilead breaks through with first approval for new HIV drug

European authorities cleared Gilead’s long-acting shot for patients whose HIV infection is resistant to other drugs. An FDA decision is expected by December.

By Jonathan Gardner • Aug. 22, 2022

Digital medicine company Akili gets cold market reception after blank-check merger

After spiking on news of the merger’s close, shares in the ADHD treatment developer fell sharply in trading.

By Elise Reuter • Updated Aug. 23, 2022

US plans shift to private market sales of COVID-19 vaccines, drugs

The federal government will begin the transition as early as this fall, clearing the way for drugmakers to control sales and distribution of their medicines.

By Christopher Newman • Aug. 17, 2022

UK approves Moderna’s two-pronged COVID-19 booster

Britain’s drug regulator is the first public health authority to clear a vaccine designed to fight omicron as well as the original strain of the virus. 

By Jonathan Gardner • Aug. 15, 2022

Pfizer’s new pneumococcal vaccine meets study goal in children

Pfizer, which competes with Merck in this market, plans to ask the FDA for an expanded approval of its 20-valent shot later this year.

By Delilah Alvarado • Aug. 12, 2022

GSK, Pfizer, Sanofi shares drop amid Zantac litigation concerns

The companies could face liability related to their sales of the heartburn drug, which was withdrawn from the market in the U.S. and other countries after impurities related to a likely carcinogen were detected.

By Ned Pagliarulo • Updated Aug. 11, 2022

Coherus wins FDA approval for second Lucentis biosimilar, its third drug

The biotech company secured a valuable interchangeable designation for the copycat medicine, which it plans to launch later this year.

By Kristin Jensen • Aug. 3, 2022

With new data, Roche takes step toward more convenient cancer immunotherapy

The pharma claimed Phase 3 study success for a subcutaneous version of its drug Tecentriq, a strategy it and rivals Merck and Bristol Myers could use to extend the market life of their lucrative drugs.

By Ben Fidler • Aug. 2, 2022

AbbVie cancer drug sales fall as AstraZeneca competitor gains ground

Imbruvica, long one of AbbVie’s top-selling medicines, has ceded market share in treating chronic lymphocytic leukemia to AstraZeneca’s Calquence.

By Ned Pagliarulo • July 29, 2022

Pfizer sales of COVID-19 vaccine, pill beat forecasts as company prepares for future waves

The company plans to ready a booster shot by the fall that targets the BA.4 and BA.5 strains that are currently most prevalent in the U.S. and other countries.

By Christopher Newman • Updated July 28, 2022

Teva reaches deal in principle to settle opioid lawsuits for over $4B

The generics maker joins other pharmaceutical companies attempting to resolve litigation over their alleged contributions to the opioid epidemic.

By Kristin Jensen • July 27, 2022

Amazon will see you now: reading between the lines of the One Medical acquisition

The deal’s near-term effects might not be large, but Amazon’s acquisition still threaten’s One Medical’s primary care competitors and others seeking a greater slice of the market, experts said.

By Rebecca Pifer • July 25, 2022

EU speeds approval of monkeypox vaccine as WHO declares public health emergency

Vaccine maker Bavarian Nordic said it is meeting demand for its shot with production capacity of 30 million doses a year.

By Christopher Newman • July 25, 2022