Novartis plant cleared to produce in-demand cancer drug

The FDA has approved the pharma, which has had difficulty producing radiopharmaceutical drugs, to make its treatment Pluvicto at a New Jersey site.

By Delilah Alvarado • April 24, 2023

Ionis, AstraZeneca detail data backing rare disease rival to Alnylam drugs

A second-generation treatment called eplontersen halted nerve damage and improved quality of life in a late-stage study the companies are using to seek U.S. approval.

By Ned Pagliarulo • April 24, 2023

Explore the Trendline➔

Top 5 stories from BioPharma Dive

Looming patent expiries this decade and intensifying competition from China are forcing drugmakers to adapt, while new opportunities open up in oncology and in neuroscience.

By BioPharma Dive staff

Partnership is key to caring for multiple sclerosis patients throughout their journey

Empowering people to live healthier goes beyond developing the right treatments.

By Anne Berger, Head of Alliance Development, Viatris • April 24, 2023

The rise of AI in pharma: make it work for you

 AI-derived data can range from insightful to useless. Learn how to get one and not the other.

April 24, 2023

FDA approves earlier use of Roche’s Polivy in common form of lymphoma

The agency’s decision also converts the biologic drug's approval from accelerated to full, confirming an earlier OK based on tumor responses.

By Jonathan Gardner • April 20, 2023

Appeals court sides with Amgen in patent fight over psoriasis drug Otezla

With the court victory, the biotech giant could stave off a set of generic competitors for the top-selling drug until 2028.

By Kristin Jensen • April 20, 2023

J&J leans on cancer drug sales to maintain first quarter growth

Revenue topped analyst forecasts on strong market performance from the pharma’s multiple myeloma treatments, as well as the last quarter of significant COVID-19 vaccine sales.

By Christopher Newman • April 18, 2023

GSK to buy Bellus Health and its chronic cough drug for $2B

The acquisition gives GSK a competitor to a similar drug being developed by Merck for the condition, which the companies estimate affects millions of people in the U.S.

By Ned Pagliarulo • April 18, 2023

Vaxcyte strengthens case for experimental pneumococcal vaccine

The company reported positive results from a second Phase 2 study of a shot that’s meant to challenge vaccines from Pfizer, Merck and GSK.

By Delilah Alvarado • Updated May 3, 2023

Navigate the complexities of cell and gene therapies

See how the effective use of CMC expertise helped guide a biopharma company’s development of a CGT product.

April 17, 2023

FDA again knocks back Alvotech’s Humira biosimilar

The agency rejected the partners’ copycat version of AbbVie’s blockbuster drug for a second time, citing problems spotted during the inspection of a manufacturing facility.

By Jonathan Gardner • April 14, 2023

Novo boosts sales outlook on strong demand for obesity drug

The Danish drugmaker nearly doubled the 2023 forecasts for Wegovy and Ozempic in the latest indicator of the sales potential of an emerging and competitive class of weight loss drugs. 

By Kristin Jensen • April 13, 2023

FDA, citing safety concerns, places partial hold on Merck KGaA’s MS drug

Evidence of possible liver damage among study participants adds to growing concerns about the potential of BTK inhibitors to treat MS, a strategy being pursued by several large drugmakers. 

By Kristin Jensen • April 12, 2023

AbbVie removes two approvals for blood cancer drug Imbruvica

In paring back use of Imbruvica, the drugmaker has become the latest developer to voluntarily withdraw indications for a cancer medicine following a setback in confirmatory testing.

By Delilah Alvarado • April 7, 2023

In NEJM, full Pfizer data show RSV vaccine’s protection

Shots from Pfizer and GSK could soon become the first approved for the common respiratory infection. Results published in the high-profile medical journal give a closer look at the former.

By Delilah Alvarado • Updated April 6, 2023

Pharma partner Sartorius eyes gene therapy market with $2.6B deal

The biotech tools supplier is acquiring Polyplus, a French company that makes components essential to the viral vector backbones of gene therapies.

By Ned Pagliarulo • March 31, 2023

Acquired patents aid J&J defense of top-selling drug from biosimilar challenge

The company is asserting patents gained via its 2020 acquisition of Momenta in litigation to forestall entry of a biosimilar to its psoriasis drug Stelara.

By Jonathan Gardner • March 29, 2023

Novartis, following Lilly, claims success in early breast cancer study

The Swiss drugmaker believes the findings could support an approval of Kisqali in adjuvant breast cancer and, potentially, broader use than Lilly’s rival drug Verzenio.  

By Jonathan Gardner • March 27, 2023

Pfizer returns cancer immunotherapy rights to Merck KGaA

Analysts had speculated Pfizer might divest its Bavencio interest to help close its Seagen buyout. A Pfizer spokesperson said the move was “conceived independently” of any other deal, however.

By Ned Pagliarulo • March 27, 2023

Biosimilar brands bring buzz to pharma marketing

Bracing for biosimilars? Learn how biosimilar launches differ from traditional biologics.

March 27, 2023

The 3 biggest barriers to patient services program utilization

Not getting traction with your patient services program? Here’s why and what to do about it.  

March 27, 2023

Novo partners with Dewpoint to mine an emerging field for new drugs

The companies will collaborate to identify compounds that could treat insulin resistance by targeting shape-shifting cellular droplets known as biomolecular condensates.

By Delilah Alvarado • March 22, 2023

Merck TIGIT drug misses goal in lung cancer trial, adding to doubts over approach

The combination drug didn’t help patients any more than chemotherapy, but Merck will continue the trial to test it together with chemo.

By Jonathan Gardner • March 17, 2023

In Pfizer-Seagen review, FTC has chance to set new pharma precedent

The regulator’s review of the planned $43 billion deal could reveal how it plans to apply a new philosophy toward drugmaker mergers.

By Jonathan Gardner • March 14, 2023

VA to cover Leqembi for veterans with early Alzheimer’s

The agency’s decision on Eisai and Biogen’s new drug contrasts with a stringent Medicare policy that limits coverage to patients in clinical trials.

By Christopher Newman • March 14, 2023