Tedros Adhanom Ghebreyesus, Director General of the WHO (Salvatore Di Nolfi/Keystone via AP Images)

WHO OKs mol­nupi­ravir as treat­ment for Covid-19, af­ter new da­ta from In­dia

The WHO up­dat­ed its guide­lines on Wednes­day to rec­om­mend mol­nupi­ravir, Mer­ck’s an­tivi­ral pill, for treat­ing pa­tients new­ly di­ag­nosed with Covid-19.

It’s the first Covid-19 pill rec­om­mend­ed by the WHO, com­ing be­fore any rec­om­men­da­tion around Pfiz­er’s Paxlovid, de­spite con­tin­ued ques­tions about the pre­cise mag­ni­tude of ben­e­fit and the risks as­so­ci­at­ed with the Mer­ck drug.

The new de­ci­sion, how­ev­er, comes af­ter a tri­al in In­dia on a gener­ic ver­sion of mol­nupi­ravir found the pill re­duced the risk of hos­pi­tal­iza­tion from Covid-19 by 65%. Al­though not con­clu­sive, it was an­oth­er da­ta point in the on­go­ing de­bate over mol­nupi­ravir’s ef­fi­ca­cy. Mer­ck’s ini­tial da­ta showed the pill cut the risk of hos­pi­tal­iza­tion among high-risk Covid-19 pa­tients in half, but lat­er analy­ses of the same tri­al cut that num­ber to just 30% — a drop the com­pa­ny strug­gled to ex­plain to the FDA.

Lab stud­ies show the ef­fi­ca­cy should be un­af­fect­ed by new vari­ants such as Omi­cron.

WHO nod­ded to those risks in its state­ment, ad­dress­ing them in a sim­i­lar fash­ion to how US health agen­cies ad­dressed them. The glob­al health body said the drug should be pre­scribed on­ly for pa­tients with the “high­est risk of hos­pi­tal­iza­tion,” such as the un­vac­ci­nat­ed, the im­muno­com­pro­mised, old­er adults and peo­ple with chron­ic con­di­tions.

And, like the FDA, they ad­vised against pre­scrib­ing it in preg­nant women. That’s be­cause of the drug’s mech­a­nism of ac­tion — it in­duces a lethal num­ber of mu­ta­tions in the coro­n­avirus genome — and it could al­so in­duce mu­ta­tions in hu­mans. Some lab stud­ies sug­gest it’s pos­si­ble, al­though the ex­act risk to pa­tients who take the pill for just the rec­om­mend­ed five days re­mains un­known and Mer­ck has pre­sent­ed ev­i­dence to sug­gest it’s min­i­mal.

Mer­ck has tak­en steps to make the drug avail­able glob­al­ly, sign­ing li­cens­es with gener­ic drug­mak­ers in In­dia and strik­ing an agree­ment with the Med­i­cines Patent Pool, a UN-backed non­prof­it that will work to make the pill avail­able in 105 low- and mid­dle-in­come coun­tries.

Crit­i­cism of the drug has not abat­ed, though. On Thurs­day, James Bro­phy, a pro­fes­sor of med­i­cine at McGill Uni­ver­si­ty, pub­lished an op-ed in the British Med­ical Jour­nal ques­tion­ing the UK’s de­ci­sion to au­tho­rize the drug and point­ing to the safe­ty con­cerns and lin­ger­ing ques­tions over its ex­act ef­fi­ca­cy.

These ques­tions have af­fect­ed up­take in the US. Even as Omi­cron surged in the US, mol­nupi­ravir sat on shelves at many phar­ma­cies across the coun­try. In Feb­ru­ary, the Fi­nan­cial Times re­port­ed that the EMA might de­ny au­tho­riza­tion for the pill over those con­cerns.


Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

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Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

TScan Therapeutics' departing CEO David Southwell and CSO/COO Gavin MacBeath

TCR up­start an­nounces CEO ex­it, with CSO now act­ing re­place­ment

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.

Sar­to­rius to ac­quire French man­u­fac­tur­er for $2.6B+ in cell and gene ther­a­py play

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.

Austin biotech Mol­e­c­u­lar Tem­plates lays off more than 100 staffers as pipeline nar­rows

Molecular Templates is ridding itself of a Phase I HER2 asset and fine-tuning its pipeline to focus on three programs and a preclinical Bristol Myers Squibb collaboration. With the narrowed scope on its so-called engineered toxin bodies, the Austin, TX biotech is laying off about half of its staff.

That’s a little more than 100 employees, per an SEC filing. Molecular’s layoffs, approved by its board Wednesday, add to the dozens of pullbacks in the industry in the first three months of 2023.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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