Two cancers studies are slated to grab significant attention at the upcoming American Society of Clinical Oncology 2023 annual meeting, and each could lead to a major label expansion for the companies involved. With KEYNOTE-671, Merck is looking to shake up how nonmetastatic non-small cell lung cancer (NSCLC) is treated by testing Keytruda both before and after surgery. For its part, Novartis will elaborate on the postsurgery data for Kisqali in early breast cancer from the NATALEE trial. When the company said the trial met its endpoint, investors sent the Big Pharma’s stock price up by 8% in a single day. Before the official data revelations on June 2 for NATALEE and June 3 for KEYNOTE-671, Fierce Pharma gathered expectations for the two studies from oncology leaders at Penn Medicine and MD Anderson Cancer Center plus market analysts at multiple firms. The NATALEE study could open a market that’s worth ...
Johnson & Johnson’s idea to carve out the prostate cancer indication from GSK’s PARP inhibitor Zejula has yielded its first global approval. Following a recommendation from the European Medicines Agency, the European Commission has officially approved J&J’s Akeega in metastatic castration-resistant prostate cancer (mCRPC), J&J said Friday. The drug is a fixed-dose combo of Zejula and J&J’s androgen-directed Zytiga, and it’s used alongside a corticosteroid. Under a 2016 deal with Zejula’s developer Tesaro, J&J specifically carved out rights to the drug in prostate cancer. GSK then bought out Tesaro in 2019. Not all patients can get Akeega under the drug’s European label. To be eligible, a patient’s tumor must test positive for BRCA1/2 mutations, which account for 10% to 15% of all cases, J&J said. Akeega’s label in Europe is narrower than that of rival PARP inhibitor Lynparza from AstraZeneca and Merck. The European Commission in December cleared Lynparza and Zytiga for mCRPC ...
Merck on Thursday reported first-quarter revenue and adjusted earnings that topped Wall Street’s expectations, despite a steep drop in sales of its Covid antiviral treatment molnupiravir. Sales of molnupiravir plunged to $392 million during the period, down 88% from the $3.2 billion reported for the first quarter of 2022. Merck said the decrease is primarily the result of lower sales in the U.S., U.K., Japan and Australia. The company reported total revenue of $14.5 billion for the quarter, down 9% from a year earlier. But excluding the Covid drug, Merck said its revenue grew 11%. Here’s what Merck reported compared with Wall Street’s expectations, based on a survey of analysts by Refinitiv: Earnings per share: $1.40 adjusted, vs. $1.32 expected Revenue: $14.49 billion, vs. $13.78 billion expected Merck’s stock closed more than 1% higher Thursday. The shares are up more than 3% for ...
Dive Brief: The Food and Drug Administration told Merck KGaA not to give an experimental drug for multiple sclerosis to new patients and to pause treatment for study participants who have been on it for less than 70 days amid concerns about possible liver damage. Regulators acted after laboratory tests suggested the livers of two patients might have been adversely affected by the drug, known as evobrutinib. However, neither patient exhibited symptoms and their liver enzyme levels returned to normal after they stopped taking the medicine, Merck KGaA said Wednesday. The German drugmaker had already fully enrolled a Phase 3 study known as Evolution, and that program will continue as planned because all the patients have already had received the medication for at least 70 days. Results are still expected in the fourth quarter. Dive Insight: Evobrutinib is part of a class of drugs known as BTK ...
Merck & Co. and Healthy Interactions alliance’s Map4health, a new digital and mobile service catering to diabetes patients, is designed for connecting patients with doctors to educate and help them between clinic visits.
Merck and Healthy Interactions, a healthcare firm for people that provides digital and personal solutions for management and education of chronic illnesses, jointly started a diabetes management and engagement platform which encourages personal counselling programs.
HitGen and Merck have updated their licensing agreement to a full-fledged drug discovery collaboration in order to screen DNA-encoded libraries for new small-molecule assets.
96-week data on doravirine, Merck’s HIV drug, was posted by the drugmaker recently. Merck expects it to outrun drugs like Bristol-Myers Squibb’s Sustiva in combination regimens and antiretroviral drugs from AbbVie and Johnson & Johnson in viral suppression.
On Wednesday, a day after Keytruda got the thumbs up for cervical cancer, the drug was approved for treatment of a rare form of non-Hodgkins lymphoma patients who cancer returned after at least two previous treatment lines. Last year, Keytruda also got an indication for classical Hodgkin lymphoma.
In a major setback for Eisai and Merck & Co, the FDA has stalled the roll-out of Lenvima as a treatment for earlier untreated liver cancer patients. Big things were expected by Merck & Co when Eisai’s Lenvima was scheduled to be launched in March. Merck has agreed to shell out USD 5.8 billion on half of the liver cancer’s drug sales.
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