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,
First therapy for rare joint tumor approved by the FDA
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.
Bayer recall
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.
Novartis’ sickle cell disease candidate gets quick FDA review
Jazz launches Sunosi
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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University of Penn researchers find a new method for fighting cancer cells
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 to buy Allergan
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.
Jazz Pharmaceuticals planning a July launch of Sunosi
Who were the 20 highest paid CEOs in 2018?
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.
ASCO 2019
As ASCO 2019 comes to an end in Chicago, click here to learn about all the latest oncology news.
Novartis’ gene therapy drug, Zolgensma to cost $2.1 million
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.
CSL Behring names new COO
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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FDA questions credibility of Daiichi data
Drug prices coming to TV ads
Alexion's Ultomiris and Soliris launch results
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 recalls fentanyl patches
Catalent to purchase Paragon Bioservices
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.
2018 top 15 pharmaceutical companies by revenue
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 provides Phase 3 data
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.