By Tristan Manalac Pictured: Novartis Institutes for BioMedical Research building in California/iStock, JHVEPhoto Novartis on Tuesday confirmed that it is pushing through with the spin-off of its generics and biosimilars division Sandoz, pending the final approval of its shareholders. To secure approval, the Swiss pharma group will hold an extraordinary general meeting set for Sept. 15. If given the go-ahead, Novartis expects to complete Sandoz’s spin-off “on or around” Oct. 4, the company said in Tuesday’s announcement. Novartis is also planning to list Sandoz on the SIX Swiss Exchange, with an American Depository Receipt (ADR) program in the U.S., for which the pharma group will likewise need to secure regulatory approvals. Novartis first launched a strategic review of its generics unit in October 2021, when it announced that it was exploring options for the business moving forward—including a potential sale. At the time, Sandoz was seeing better volume sales figures ...
When it comes to heart failure medication, a labeling mix-up can have dire consequences. That’s why Marlex Pharmaceuticals of New Castle, Delaware, is recalling two lots of digoxin tablets at the 0.125-mg and 0.25-mg doses. The company is pulling the batches of the heart failure medication because certain bottles of 0.125-mg digoxin tablets are mislabeled with the 0.25-mg dose and vice versa. The labeling snafu could cause either overdosing of underdosing in patients who unknowingly take the wrong strength of medication, Marlex warned in a notice posted on the FDA’s website. Patients on 0.125-mg strength digoxin who take the higher dose could experience “significant drug toxicity” such as mental disorientation, dizziness, blurred vision, memory loss and fainting, the company added. Meanwhile, patients who take a subpotent dose may experience loss of control of heart rate and potential heart failure exacerbation, Marlex said. As of Thursday, Marlex said it hadn’t received ...
It is a bleak view for Outlook Therapeutics’ wet age-related macular degeneration (AMD) treatment plans after the US Food and Drug Administration (FDA) rejected a biologic licence application (BLA) for the company’s bevacizumab-vikg candidate. Shares in Outlook Therapeutics fell a hefty 80% when the market opened on 30 August. Prior to the FDA’s complete response letter (CRL), a GlobalData consensus estimated Outlook to potentially earn $989m in 2029 if the drug was approved. GlobalData is the parent company of Pharmaceutical Technology. Despite ONS-5010 (bevacizumab-vikg) demonstrating positive results in a trial – meeting safety and efficacy endpoints, the agency noted several manufacturing issues and the need for additional confirmatory clinical data. In a conference call on 30 August, Outlook Therapeutics’ CEO Russell Trenary said: “We are disappointed, and we were certainly not expecting to receive a CRL back from the FDA.” He added that the company believes the chemistry, manufacturing, and ...
Biocon’s troubled Malaysia manufacturing facility has been slammed once again by the FDA. After a recent inspection, the regulator cited the plant for eight observations. The latest citation follows an FDA visit to the site from July 10 to July 20. Afterward, the FDA wrote up its findings in a Form 483 filing that highlights inadequate corrective and “repeat” problems that it observed on previous visits. In a letter posted on the FDA’s website, Biocon was cited for a number of ongoing issues such as scissors stored in non-sterile holders being used to open “bags of sterile components,” improper blockage of air filters, insufficient cleaning of sterile machinery and numerous problems with batch testing and record-keeping. The filing, which contained numerous redactions, also cited Biocon’s failure to lay out detailed, written guidelines for some manufacturing operations. “Specifically, your firm has no written procedures on what corrective actions are to be ...
In reporting its first-quarter earnings, Biogen said it would halt the development of at least four investigational drugs to allow the company to focus on more lucrative opportunities.On Tuesday, Biogen revealed what those opportunities—and its other cost-cutting measures—would entail, saying (PDF) it would reduce its headcount by 1,000 by 2025. With the company starting 2023 with 8,725 employees, that’s an 11.5% reduction of the workforce. At the start of 2022, Biogen employed (PDF) 9,610 people, according to an SEC filing. The numbers show that Biogen has already been working to downsize in the wake of the disastrous Aduhelm launch for Alzheimer’s disease. The latest measures will save Biogen $1 billion in operating expenses by 2025, the company estimates, with roughly $300 million of that earmarked for re-investment as Biogen launches key products, including newer Alzheimer’s disease drug Leqembi, which gained a full approval from the FDA earlier this month. Biogen’s shift comes ...
Pictured: Johnson & Johnson Sign in Silicon Valley/Shutterstock, Michael Vi Johnson & Johnson exceeded Wall Street expectations in its second quarter performance. The healthcare products giant posted sales of $25.5 billion in its earnings report on Thursday. Worldwide sales numbers reflected a 6.3% growth for J&J with revenue close to $1 billion higher than analysts expected, thanks in particular to a nearly 10% increase in its medtech sales. Medtech has been on the rebound since patients have returned to non-emergent surgeries like knee and hip replacements, which saw a significant drop during the pandemic. Operational sales for the company’s pharma arm, suffering growth points due to dwindling COVID-19 vaccine sales, was up 3.9%. The second quarter posted no U.S. sales of J&J’s COVID vaccine, with no domestic revenue expected beyond the $747 million from outside the U.S. reported last quarter. Its government contracts are now complete. Primary growth drivers were J&J’s oncology and immunology ...
Just days after sewing up a pair of $897 million deals with Pfizer, Samsung Biologics has added a few hundred million dollars more to its partnership cash pile—this time courtesy of an expanded pact with Novartis. Monday, Samsung Bio said in a regulatory filing that it’s inked a $390.9 million deal to help crank out Novartis drugs. The latest production pact builds on an earlier Samsung-Novartis tie-up worth $81 million in June 2022. Last week, meanwhile, Samsung Bio said Pfizer had added $486 million to two biosimilar production accords the companies made in early 2023. In June, the partners signed a contract for the Korean CDMO to produce biosimilar drugs in the fields of immunology, oncology and inflammation. And in March, the companies linked up on a deal worth $193 million, according to a regulatory filing. Samsung’s Novartis deal comes in below that Pfizer deal from June. Still, the Novartis tie-up now represents ...
Another biosimilar product copying Johnson & Johnson’s top-selling drug Stelara may enter the U.S. market without a patent infringement challenge by early 2025 thanks to a new settlement.J&J has signed an agreement granting Alvotech and Teva a license for their proposed Stelara biosimilar, AVT04, in the U.S. The settlement allows the biosimilar makers to launch their version no later than Feb. 21, 2025, the companies said Monday. The new Stelara biosim deal follows another one J&J recently inked with Amgen, which gives the latter a license to launch its copycat no later than Jan. 1, 2025. Like Amgen, Alvotech and Teva haven’t gotten the FDA’s blessing for AVT04. The pair in January said the FDA had accepted its application with a decision targeted for the second half of this year. A verdict for Amgen’s version is expected by the end of the third quarter. Settling those biosimilar entry dates is ...
Swiss pharma giant Roche is looking to put its biologics manufacturing facility in Vacaville, California, on the auction block or shutter it by 2029, Reuters reports. In a statement to Reuters, the company didn’t directly respond to the prospect of selling or closing the facility but said it no longer needs large volumes of the products being manufactured at the site. However, internal emails sent to employees and obtained by the news agency indicated that if a buyer weren’t identified, Roche would begin winding down operations at Vacaville and shutter the plant between 2028 and 2029, Reuters reports. The plant, which employs about 800 people, produces monoclonal antibodies, according to the news service. Roche is currently staving off challenges to its revenue flow thanks to biosimilar challengers to its big-selling cancer drugs Herceptin, Avastin and Rituxan. This has forced the company to rely on newer products to deliver growth. Roche ...
After the recent high-profile loss of exclusivity for AbbVie’s megablockbuster immunology drug Humira, industry watchers’ eyes moved to Johnson & Johnson’s Stelara as one of the next major drugs expected to face biosim competition. Tuesday, the industry got more information about when exactly that biosimilar clash might occur. In J&J’s patent case over Amgen’s proposed biosimilar to J&J’s Stelara, the companies have settled, according to a Tuesday filing in Delaware federal court. An Amgen spokesperson told Reuters the deal will allow the company to launch its Stelara biosimilar “no later than January 1st, 2025.” With that, the market exclusivity clock is ticking on J&J’s biggest drug by sales. Last year, the medicine pulled down $9.72 billion across its range of indications, including plaque psoriasis, psoriatic arthritis and Crohn’s disease. Amgen has yet to win FDA approval for its proposed biosimilar. The company filed its biosim application last November, so the ...
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