Re­call re­port: Nos­trum ex­pands re­call of di­a­betes drug met­formin af­ter car­cino­gen con­cerns

Gener­ic met­formin has been a thorn in drug­mak­ers’ sides for months af­ter a prob­a­ble hu­man car­cino­gen was found in test­ed lots. Now, one of the com­pa­nies is ex­pand­ing its re­call to an­oth­er lot of the drug.

Nos­trum Lab­o­ra­to­ries out of Kansas City, MO vol­un­tar­i­ly re­called one lot of met­formin HCl ex­tend­ed re­lease tablets, USP 750 mg, a type 2 di­a­betes drug (the gener­ic equiv­a­lent to Glu­cophage tablets) af­ter test­ing dis­cov­ered el­e­vat­ed lev­els of ni­trosamine, the prob­a­ble car­cino­gen.

The re­call is an ex­pan­sion of a pre­vi­ous Nos­trum re­call in No­vem­ber for the same prod­uct and the same rea­son­ing, the FDA said. The pills at is­sue from the No­vem­ber re­call were a low­er dosage of 500 mg.

Met­formin is used to im­prove blood glu­cose con­trol in adults with type 2 di­a­betes mel­li­tus, and is an off-white, ob­long tablet stamped with “NM7”. The lot in Mon­day’s re­call is MET200501, with ex­pi­ra­tion dates of Ju­ly 2022.

Nos­trum has not been no­ti­fied of any ad­verse ef­fects from the now-re­called prod­uct, the FDA said. Any­one tak­ing met­formin who is con­cerned about the re­called batch is asked to con­sult with their physi­cian be­fore they stop tak­ing the drug, as do­ing so could be dan­ger­ous.

The ex­pand­ed re­call is the lat­est in a line of at least eight man­u­fac­tur­ers across the globe tak­ing met­formin off the shelves. In Oc­to­ber, In­dia’s Mark­sans Phar­ma pulled back an eye-pop­ping 76 lots of its met­formin ver­sion; in Sep­tem­ber, Sun Phar­ma re­called one lot of its Ri­omet ER, an ex­tend­ed-re­lease ver­sion of the drug; in Au­gust, Bayshore Phar­ma­ceu­ti­cals re­called one lot each of its 500- and 750-mg ex­tend­ed-re­lease met­formin; and in Ju­ly, Lupin Phar­ma­ceu­ti­cals pulled all lots of its ex­tend­ed-re­lease met­formin.

All re­calls were linked to high ni­trosamine lev­els found in the com­mon­ly used drug.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Michelle McMurry-Heath, BIO CEO (BIO via YouTube)

BIO looks to re­struc­ture, lay­ing off staff amid chal­lenge to the trade org's nor­mal face-to-face style

The biopharma industry, on the whole, had a red-letter year in 2020 amid Covid-19, with fundraising at an all-time high and major players speeding vaccines ahead to approval. But for BIO, the industry’s leading trade organization, the pandemic has prompted a reconsideration of the game plan.

BIO will pivot to digital as the Covid-19 pandemic continues to rage, making “some staff reductions” as it looks to bring its roughly 37,000 in-person meetings each year to the web, the organization said Thursday.

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Northway Biotech's new manufacturing facility in Greater Boston

North­way Biotech sets up shop in Boston hub, look­ing to court more cus­tomers with bi­o­log­ics-fo­cused plant

Getting a foot in the door in Boston’s bustling biopharma hub is a rite of passage for many companies, but it comes with a steep price tag. Lithuanian CDMO Northway — now with a new moniker — will set up a new plant in close proximity, and it’s hoping its biologics focus will find a willing customer base.

Northway Biotech (formerly Northway Biotechpharma) on Wednesday held a virtual grand opening ceremony for its $40 million Waltham, MA facility — a 30,000 square-foot cGMP manufacturing and process development plant that will widely expand on the company’s previous capabilities.

News brief­ing: Five pub­lic biotechs, over 2 days, raise $883M from fresh of­fer­ings; Bel­gian biotech ex­pands Se­ries B fund­ing

The wave of biotech IPOs we’ve been seeing in the last few days underscores that the public markets remain one of the key channels for fresh investments in drug R&D. And that trend was in full view this week as a slate of biotechs nailed down hundreds of millions of dollars in fresh funds.

One of the big winners of the week is Editas $EDIT, which nailed $231 million to back its pioneering work on a gene editing platform. The biotech sold 3.5 million shares at $66 each.

Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

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Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.