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.
After its May 2019 FDA approval, Jazz Pharmaceuticals is hitting the ground running with its launch of Sunosi, used to treat narcolepsy, but also for patients with obstructive sleep apnea (OSA).
Jazz estimates 12 million people in the U.S. have been diagnosed with OSA, but it believes many others have gone undiagnosed.
The campaign, called “A Different Kind of Tired,” is centered on research that found 36% of sleep apnea patients missed activities or events, avoided social situations or gave up activities because of excessive sleepiness.
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Researchers at the University of Pennsylvania have found a new method for attacking MYC, a cancer-causing gene that has proven difficult to target with drugs.
They have found that by blocking the protein, called ATF4, causes cancer cells to make too much of another type of protein family called 4E-BP. That causes the cancer cells so much stress that they die.
The researchers believe that the discovery, published in the journal Nature Cell Biology, could spark new ideas for cancer therapeutics, because experimental compounds that block the synthesis of ATF4 have already been developed.
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AbbVie, a biopharmaceutical company, said it plans to buy Botox maker Allergan for about $63 billion, to help reduce its reliance on blockbuster arthritis treatment Humira.
Humira, the world's best-selling drug, already has cheaper versions available in Europe and has its US patents expiring in 2023.
After the Drug Enforcement Agency marked Sunosi with a Schedule IV designation, Jazz Pharmaceuticals, a biopharmaceutical company, is now planning a July launch.
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.
As ASCO 2019 comes to an end in Chicago, click here to learn about all the latest oncology news.
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, helped in part by Haegarda for treating hereditary angioedema, and Idelvion, a factor IX hemophilia B treatment.
Paul will develop strategy and oversee the global supply chain.
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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.
On Wednesday, the HHS announced a ruling that will require drugmakers to provide the price of their products to the public in TV commercials and they only have about two months to make the changes.
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.
Catalent has bought Paragon Bioservices, a contract development and manufacturing organization for $1.2 billion. This is the second major buyout of a gene therapy manufacturer in the last three weeks.
This deal will get Catalent a newly completed commercial-scale manufacturing facility near Baltimore and position Catalent firmly to capture some of the $40 billion gene therapy market.
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.