Johnson & Johnson has spent years defending itself against talc claims that its baby powder caused cancer and has sometimes suffered costly losses. But the company has had success in appeals, and that trend continued Tuesday with the reversal of a $110 million verdict.
Merck has not given up on antibiotics. This year, Zerbaxa, an antibacterial combination product has had a label expansion and its newly approved Recarbio has met its endpoints in a phase 3 test against hospital-acquired and ventilator-associated bacterial pneumonia in adult patients that could lead to a label expansion.
After finding trace amounts of an “unexpected impurity,” Torrent Pharmaceuticals Limited has expanded its voluntary recall of losartan potassium tablets. The impurity is N-Methylnitrosobutyric acid.
The expanded recall includes an additional three lots of losartan potassium tablets USP and two lots of losartan potassium/ydrochlorothiazide tablets. Only lots of losartan NMBA above the acceptable daily intake levels released by the FDA are being recalled.
AstraZeneca’s Imfinzi, which enables the immune system to detect and attack certain cancer cells, when combined with chemotherapy has been shown to lengthen patient’s lives with an aggressive type of lung cancer by nearly to three months.
Pivotal phase 3 data for The Medicines Company’s longer-lasting PCSK9 cholesterol fighter shows the drug is at least as safe and effective as its two marketed rivals - Amgen's Repatha and Sanofi and Regeneron's Praluent.
After a six week trial a judge has ruled that Johnson & Johnson must pay $572 million as part of an opioid abatement plan. J&J fought hard against Oklahoma's claims the company played a "kingpin" role in the state’s opioid epidemic, but its lawyers fell short in those efforts.
Nabriva has received its first FDA approval for Xenleta, a drug used to treat community-acquired bacterial-pneumonia (CABP) in adults. CABP affects around 5 million Americans each year. The drug, which can be given orally or intravenously, is the first in a new class of antibiotics called pleuromutilins,
Last week Bayer discovered that vials of one of their top-selling hemophilia drugs had been filled with the wrong medicine. The vials are labeled as containing Kegenate FS but they actually are filled with VIII hemophilia A treatment Jivi. All but 990 vials were caught before they made it into the marketplace.
The FDA has accepted a Novartis’ biologics application for its sickle cell disease candidate crizanlizumab (SEG101). This puts the drug under priority review, which slashes four months off its evaluation time to just six months in total.
FiercePharma has calculated the top CEO pay packages in biopharma in 2018. The salaries range from nearly $60 million down to $16 million. Amongst the data are some notable trends. First, no women made the list. Emma Walmsley, Big Pharma’s only women CEO had a pay package of $7.75 million, which if doubled still would not make the top 20. Other Big Pharma CEOs not on the list are Novartis, Roche and Sanofi.
After Friday’s FDA approval of Novartis’ gene therapy drug, the company has set a $2.1 million price tag for the one-time treatment. Zogensma has been approved for treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA). The price will make it the world’s most expensive drug.
Paul McKenzie, who joined Biogen in 2016 as executive vice president of pharmaceutical operations and technology, has been named Chief Operating Officer at CSL Behring in King of Prussia, PA. CSL Behring, a leading global biotech company, saw its share price rise 30% in 2018,
The FDA has moved back the PDUFA action date to August for Daiichi Sankyo’s quizartinib, used for the treatment of acute myeloid leukemia (AML). Current Phase 3 data, linked FLT3 inhibitor quizartinib to a 1.5 month improvement in overall survival (OS) over chemotherapy.
Alexion, a global biopharmaceutical company, announced its first quarter earnings last week which included numbers on its recent launches of Ultomiris, a new treatment option for adult patients living with paroxysmal nocturnal hemoglobinuria (PNH) and Soliris, as a treatment for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody-positive.
Alvogen, a global pharmaceutical company, is voluntarily recalling two lots of Fentanyl Transdermal System 12 mcg/h transdermal patches to the consumer level be “a small number of cartons” labeled as 12 mcg/h actually contain 50 mcg/h patches, according to the notice distributed Friday by the FDA.
There aren’t too many surprises in Fierce Pharma’s list of the top 15 Big Pharma companies in 2018. Johnson & Johnson, Roche, Pfizer, Novartis and Merck & Co were listed in the top 5 with Sanofi slipping 2 spots to number 7 and Gilead slipping 3 spots to number 13. Companies moving up the ranking were Bristol-Myers Squibb who moved up from 15 to 12 after buying Celgene. For next year, keep an eye on Takeda who recently purchased Shire.
Astellas, a pharmaceutical company, received FDA approval for Xospata in November 2018. This drug is for treatment of adult patients who have relapsed or refractory acute myeloid leukemia with the FLT3 mutation.
On Monday at American Association for Cancer Research annual meeting, Astellas released Phase 3 data that showed that patients lived a median 9.3 months after therapy, compared with 5.6 months for those receiving salvage chemotherapy.
With so much growth in the area of gene therapies, Thermo Fisher Scientific, an american biotechnology product development company, has decided to buy Brammer Bio, a contract development and manufacturing organization (CDMO) focusing on manufacturing viral vectors for gene and cell therapies.
Sage Therapeutics, a clinic stage biopharmaceutical company, has received the first FDA approval for treatment of postpartum depression. Zulressa has a 60-hour IV infusion schedule for treatment which could make it challenging for new moms to receive treatment.
FDA Commissioner, Scott Gottlieb, who was appointed by President Trump in 2017 is stepping down just shy of two years into his tenure. The commissioner was popular for his market-based policies to lower drug costs and work to speed new brands to approval.