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,
Earlier this month, the U.S. Food and Drug Administration approved Daiichi Sankyo’s Turalio, the first therapy for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery. TGCT can cause incapacitating symptoms for patients such as pain, stiffness and limitation of movement.
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.
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.
In an effort to slim down its operations and pay off debt, General Electric has moved to sell its growing biopharma manufacturing business to Danaher. Danaher, a global science and technology innovator, would pay $21.4 billion in the deal which Danaher plans to have operate as a standalone business. The unit is expected to bring in about $3.2 billion in 2019 sales.
After revealing positive data from a phase 1b/2 Keynote-365 trial, Merck has stated it will run phase 3 studies testing Keytruda in tandem with Lynparza, the PARP inhibitor it shares with AstraZeneca; in a cocktail containing the chemotherapy docetaxel and steroid prednisone; and alongside Xtandi, a hot prostate cancer drug from Pfizer and Astellas.
As we settle in to 2019, FierceMedTech has provided its list of the top 2018 BioTech companies. The companies are: 10x Genomics, AblaCare, Allevi, Ceribell, Evidation Health, FineHeart, Glympse Bio, Invizius, Mekonos, Mindstrong Health, Pear Therapeutics, Potrero Medical, Profusa, Sana Health and Spry Health.
Takeda has met its goal in an ongoing Phase 3 study that covers eight countries and has enrolled more than 20,000 participants. The study, of Takeda’s shot to prevent dengue, prevented infections with four different serotypes of the virus. More results due out later this year.
After receiving FDA last month for its prescription software to treat opioid addiction, Pear Therapeutics has posted $64 million in new fundraising.
The reSET-O prescription digital therapeutic for opioid use disorder consists of a 12-week cognitive behavioral therapy program along with outpatient treatment. It includes buprenorphine, a standard medication for opioid addiction, while helping to reinforce positive behaviors through interactive therapy lessons…