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Home » Newsletters » BioWorld

BioWorld

March 15, 2023

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Gold dollar sign inside gold cog

$105M raised: Mediar wins big pharma backing for novel fibrosis therapies

Mediar Therapeutics Inc. emerged from stealth, unveiling $105 million in investment and bold ambitions to develop new ways of tackling fibrosis. Cambridge, Mass.-based Mediar is challenging what CEO Rahul Ballal called “the fundamental dogma” of fibrosis therapy: “You have to address fibrosis at its initiation, when inflammation is rampant.” Mediar, in contrast, is focused on developing therapies that either disrupt or reverse the fibrotic process, particularly when it progresses from a moderate to a severe state. Read More

Bellicum tolls for GoCAR-T; AEs in phase I/II put program in breakdown lane

Optimism for the GoCAR-T program had perked somewhat after a mid-February update, but hopes were definitively dashed as Bellicum Pharmaceuticals Inc. made known March 15 its decision to quit the phase I/II study testing two prospects in heavily pretreated cancer. The Houston-based firm’s stock (NASDAQ:BLCM) closed at 43 cents, down 50%, as Wall Street reacted to news regarding the study, designed to test GoCAR-T cell prospects BPX-601 and BPX-603 when combined with the activating agent rimiducid, a lipid-permeable tacrolimus analogue. Read More
Close up of man's eye

Further manufacturing delays cast doubt on Lumevoq despite sustained phase III efficacy

Patients with Leber hereditary optic neuropathy who received bilateral injections of Gensight Biologics SA’s Lumevoq (lenadogene nolparvovec) are continuing to see statistically significant visual improvements three years into the phase III REFLECT trial, but the missed primary endpoint at 1.5 years, along with a series of manufacturing mishaps, have left the gene therapy’s approval prospects uncertain. Read More

NMPA accepts enfortumab vedotin application from Astellas

The NMPA accepted a BLA from Astellas Pharma Inc. for enfortumab vedotin, which is designed for the treatment of patients with locally advanced or metastatic urothelial cancer who previously received treatment with a PD-1/L1 inhibitor and platinum-based chemotherapy. “In China, there were nearly 86,000 new cases of bladder cancer in 2020, and we are working with the NMPA to seek approval for enfortumab vedotin for patients with advanced stage disease,” said Ahsan Arozullah, senior vice president and head of development therapeutic areas at Astellas. Read More
Prescription drug bottles and pills

US RX pricing controls begin to kick in

Despite the new Medicare inflation rebate, the U.S. price of 27 Part B drugs grew faster than inflation in the last quarter of 2022, triggering the new rebate provision in the Inflation Reduction Act. The manufacturers of those single-source drugs will be billed for the rebates in 2025, but Medicare beneficiaries should see a drop in their coinsurance for those drugs, for the next quarter at least.  According to the Biden administration, the decrease in out-of-pocket costs for those drugs will range from $2 to as much as $390 per average dose from April 1 through June 30. Read More

What’s next for Paxlovid

Pfizer Inc.’s Paxlovid has become such a part of the COVID-19 treatment scene in the U.S. that it’s easy to forget it’s only authorized for emergency use. That could soon change. The FDA is convening its Antimicrobial Drugs Advisory Committee March 16 to consider Pfizer’s NDA for the co-packaged nirmatrelvir and ritonavir treatment. Read More

Appointments and advancements for March 15, 2023

New hires and promotions in the biopharma industry, including: Gibson, Proxygen. Read More

Financings for March 15, 2023

Biopharmas raising money in public or private financings, including: Myosin, Novan, Onkosxcel, Protai. Read More

In the clinic for March 15, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: AB, Acesion, Akeso, Astellas, Atea, Biohaven, Cantargia, Endo, Gradalis, Immutep, Medivir, Puma, Reneo, Servier, Telix, Tscan. Read More

Other news to note for March 15, 2023

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acelrx, Alora, Amplifier, Annji, Avenue, Betagenon, BMS, Cambrian, Defence, Eureka, Exscientia, Hutchmed, Macrogenics, Novo Nordisk, Orano, Synaffix, Takeda, Vesigen. Read More

Regulatory actions for March 15, 2023

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ellipses, Innoviva, Mirum, Sapience, Truebinding, Xortx. Read More

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