An Indian factory that makes drugs for export to the US and other Western nations saw an explosion, caused by a chemical solvent leak, that left 17 dead and 36 injured.The week saw Eli Lilly and Pfizer reach out to consumers directly. While Lilly is selling discounted Zepbound vials through its LillyDirect portal, potentially disrupting the compounded obesity drug market, Pfizer has launched a direct-to-consumer (DTC) website for migraine, flu, Covid, and respiratory syncytial virus (RSV) products, in a bid to create more accessible healthcare solutions.Novartis has entered into a strategic collaboration with drug delivery specialist Lindy Biosciences to develop self-administered versions of its innovative drugs. Lindy’s technology has the potential to reduce healthcare costs while also improving patient comfort and convenience.The US Food and Drug Administration (FDA) has approved
updated Covid vaccines from Pfizer and Moderna as cases surge in the country. And Bavarian Nordic has received a new order for 440,000 doses of its mpox vaccine — Jynneos — from an undisclosed European nation, as several nations come forth to donate doses to Africa to fight the monkeypox outbreak.India’s Bharat Biotech is poised to enter the global market for cholera vaccines to address a significant global shortage.In regulatory news, EyePoint Pharmaceuticals was hit with
an FDA warning letter due to manufacturing violations at its facility in
Massachusetts. And FDA widened its probe into the clinical trials held by Lykos
Therapeutics on its MDMA-assisted therapy for post traumatic stress disorder
(PTSD).Deadly blast due to chemical
leak at Indian API plant leaves 17 dead, 36 injuredAn explosion occurred at an intermediate chemicals
and active pharmaceutical ingredients (API) factory in the Indian state of Andhra
Pradesh, leaving 17 people dead and 36 injured. A leaking chemical solvent used
to make the APIs that are exported to the US and other Western countries was
found to be the cause. Staff were working to plug the leak when the blast
ripped through the unit owned by privately-held Escientia Advanced Sciences. The solvent methylene tertiary butyl ether or MTBE is a volatile and flammable liquid.Lilly to sell Zepbound vials
directly to consumers at 50% discount over WegovyEli Lilly said it will start selling low starter doses of Zepbound (tirzepatide) for much cheaper through its telehealth
platform LillyDirect, launched in January. The 2.5 mg vials of Zepbound will cost just US$ 399, which is a 40 percent discount over the monthly cost of US$ 650 for the pen version. Lilly said the prices represent a 50 percent or more discount compared to rival obesity drugs including Novo’s Wegovy (semaglutide). The drugmaker said the
move is part of its efforts to protect the public from compounded versions.Pfizer launches DTC website: Pfizer has unveiled a new website PfizerForAll, a platform aimed at streamlining healthcare access for
millions of Americans. The service caters to patients with migraines,
Covid, and flu while also facilitating vaccine bookings for preventable
diseases such as Covid, flu, RSV, and pneumonia. This end-to-end solution
offers same-day connections with qualified healthcare professionals and enables
home delivery of tests and drugs.Novartis ties up with Lindy
to develop self-administered versions of its drugsSwiss drugmaker Novartis has entered into a strategic collaboration with
drug delivery specialist Lindy Biosciences to develop self-administered
versions of its innovative drugs. Novartis is paying Lindy US$ 20 million
upfront. In return, Novartis has obtained exclusive global rights to use the biotech’s proprietary microglassifiction suspension technology. Lindy is also eligible for up to US$ 934 million if certain milestones are achieved, alongside royalties based on net sales. Lindy’s microglassifiction suspension technology enables high concentrations of biologics to be
delivered in a single dose. It will also reduce healthcare costs, while
improving patient comfort, convenience, and treatment compliance, Lindy
Biosciences said.FDA approves updated Covid
jabs from Pfizer, Moderna as virus cases surgeThe US is in the midst of a summer surge in
Covid cases and the FDA has approved updated versions of Pfizer and BioNTech’s Comirnaty and Moderna’s Spikevax that target a strain called KP.2. The Centers for Disease
Control and Prevention (CDC) has recommended that everyone six months old and
above receive an updated Covid vaccine this year.Bharat Biotech to launch oral cholera jab; Bavarian Nordic logs new Jynneos orderIndia’s Bharat Biotech said it plans to launch its oral cholera vaccine globally with the aim of making up to 200 million doses a year. The vaccine has cleared a late-stage trial, and India’s drug regulator has approved the vaccine, christened Hillchol. Bharat Biotech will now apply for the World Health Organization’s pre-qualification in order to supply it to major buyers like the UNICEF. Currently, there is a global cholera vaccine shortage of 40 million doses a year.EU nation orders 440k Jynneos doses: Danish
biotech Bavarian Nordic, with the only widely-approved mpox vaccine — Jynneos, has announced that an undisclosed European nation has contracted it to supply
440,000 doses of the smallpox and mpox vaccines. Meanwhile, Spain is donating 500,000 doses, or 20 percent of its
stockpile of Jynneos to Africa. France and Germany are donating 100,000 doses each to Africa, with the
latter doing so from its military stockpile. The US said it will donate
50,000 doses of Jynneos.EyePoint gets FDA warning
letter over manufacturing of drug-device implantEyePoint Pharmaceuticals was issued an FDA warning letter for significant violations of current good manufacturing practice (cGMP) regulations at its facility in Watertown, Massachusetts (US). The agency uncovered batch discrepancies and lackluster written procedures, many of which are related to the eye implant Yutiq. The drug-device combo contains the corticosteroid — fluocinolone acetonide. The letter said two
complaints were issued about the product not releasing the correct amount of
the drug. EyePoint sold the global rights of Yutiq to Alimera but it still receives
royalties.Lykos’ woes mount as FDA widens probe into MDMA-based trials: Not satisfied with just declining Lykos Therapeutics’ MDMA-assisted therapy for PTSD, FDA has expanded its investigation into the clinical trials
that tested it. According to a Wall Street Journal report, FDA has interviewed four people about the trials sponsored
by Lykos. Investigators asked if side effects went unreported. After FDA’s rejection, the journal Psychopharmacology retracted three papers on the MDMA-assisted therapy citing “unethical conduct” at one of the study sites.
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