Relyvrio Manufacturer Withdraws Ineffective ALS Drug From Sale
Withdrawing the drug is actually Amylyx Pharmaceuticals making good on a promise to put patients first: In a large study, Relyvrio was found not to help patients who have Lou Gehrig's disease. Among other news, Roche received FDA approval for its HPV self-test kits.
NPR:
Maker Of ALS Drug Pulls Relyvrio Off The Market, Keeping A Promise To Patients
In April, the co-CEOs of Amylyx Pharmaceuticals fulfilled a promise they made years earlier to people with the deadly disease ALS. Justin Klee and Josh Cohen, who started Amylyx while they were students at Brown University, announced that the company would voluntarily stop selling an ALS drug that had brought in $380 million in 2023. (Hamilton, 5/15)
In other drug pricing and pharmaceutical news —
Reuters:
Roche Says FDA Approves HPV Self-Test In US
Swiss drugmaker Roche on Wednesday said the US Food and Drug Administration (FDA) has approved its human papillomavirus (HPV) self-testing kit. (5/15)
Reuters:
Eisai Starts Rolling Submission For Injectable Version Of Alzheimer's Drug With US FDA
Eisai (4523.T) and partner Biogen (BIIB.O) said on Tuesday that the Japanese drugmaker has begun submitting data on a rolling basis to the US health regulator for a marketing application of a subcutaneous form of their Alzheimer's disease drug Leqembi. The companies are seeking the Food and Drug Administration's (FDA) approval of a weekly dose of Leqembi to be given as an under-the-skin injection. (5/15)
Reuters:
Novo Nordisk Owner Buys Majority Stake In Austrian Life Science Tools Company
Novo Holdings, the controlling shareholder of Danish obesity drugmaker Novo Nordisk (NOVOb.CO), said on Wednesday it would buy a controlling stake of about 60% in Single Use Support, an Austria-based life science tools company. It declined to give a precise value for the deal but a spokesperson said it would be a "high triple-digit million euros" amount. Single Use Support's two founders will each retain 10% and U.S. life sciences firm Danaher (DHR.N) will retain 20%. (Fick, 5/15)
The Wall Street Journal:
Merck KGaA Confirms Outlook After Drop In Sales, Earnings
Germany’s Merck KGaA confirmed and detailed its guidance for 2024 after it reported lower sales and earnings for the first quarter, hit by inventory reductions at its life-science segment. The life-sciences and electronics company said Wednesday that it expects full-year organic sales growth to range from 1% to 5% at the net sales level and to range from 1% to 7% in earnings before interest, taxes, depreciation, amortization and one-time items, the company’s preferred profitability metric. (Calatayud, 5/15)
