In­dia of­fers in­cen­tives to do­mes­tic drug­mak­ers for APIs; Af­ter PhI­II tri­als, Tai­ho li­cens­es Arokaris in Japan

In­dia has been de­pen­dent on the im­port of ac­tive phar­ma­ceu­ti­cal in­gre­di­ents to man­u­fac­ture its drugs. But thanks to a a re­cent gov­ern­ment ini­tia­tive, 35 of those will now be man­u­fac­tured in the coun­try.

In­dia de­pends on im­ports for 90% of its APIs, Man­sukh Man­daviya, the Min­is­ter of Health & Fam­i­ly Wel­fare and Chem­i­cals and Fer­til­iz­ers told re­porters this week. But thanks to a pro­duc­tion-linked in­cen­tive scheme brought on by the gov­ern­ment, in-coun­try phar­mas can re­ceive pay­ments over the next six years for mak­ing for­mu­la­tions, bio­phar­ma­ceu­ti­cals, ac­tive phar­ma­ceu­ti­cal in­gre­di­ents, key start­ing ma­te­r­i­al, drug in­ter­me­di­ates, and in vit­ro di­ag­nos­tic med­ical de­vices.

Right now, much of the de­pen­dence is on APIs com­ing out of Chi­na.

Af­ter PhI­II tri­als, Tai­ho li­cens­es Arokaris in Japan

Japan­ese phar­ma Tai­ho has got­ten the go-ahead to man­u­fac­ture and mar­ket the nat­ur­al killer re­cep­tor drug Arokaris for gas­troin­testi­nal symp­toms as­so­ci­at­ed with chemother­a­py.

Tai­ho got the ex­clu­sive de­vel­op­ment and mar­ket­ing rights in Japan un­der the deal with Helsinn in 2011. It sub­mit­ted a new drug ap­pli­ca­tion in March 2021. The ap­proval is based up­on the re­sults of the Phase III study CON­SOLE, com­par­ing the ef­fi­ca­cy and safe­ty in pa­tients re­ceiv­ing high­ly eme­to­genic chemother­a­py in com­bi­na­tion with palonosetron and dex­am­etha­sone.

Viet­namese phar­ma to make gener­ic mol­nupi­ravir 

Stel­lapharm has been giv­en the OK to man­u­fac­ture mol­nupi­ravir in Viet­nam to pro­duce and sup­ply the low-cost ver­sion of the Covid-19 an­tivi­ral treat­ment to sup­ply the Med­i­cines Patent Pool.

Stel­lapharm says it is the on­ly gener­ic man­u­fac­tur­er among 27 in the coun­try that has signed on to both pro­duce and sup­ply the drug to 105 low- and mid­dle-in­come coun­tries.

Stel­lapharm will use the G140, a con­tin­u­ous-mo­tion cap­sule fill­ing ma­chine from Italy to make the pills.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Roche plans to di­vest from lega­cy Genen­tech man­u­fac­tur­ing fa­cil­i­ty in Cal­i­for­nia

Roche is planning to make some changes to its subsidiary’s manufacturing network in California.

The Swiss pharma announced Wednesday that it plans to divest from Genentech’s manufacturing facility in Vacaville, CA, around 58 miles northeast of San Francisco. According to a statement from Roche, the move is part of a “broader strategy” to bring its manufacturing capabilities in line with its future pipeline. Roche is starting the process of finding a buyer for the site but has not named any candidates yet.

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Peter van de Sande, Synaffix CEO

Lon­za shells out $107M cash to snap up Synaf­fix and its ADC plat­form

After lining up a string of partnerships over the years, Dutch antibody-drug conjugate specialist Synaffix has found a new home: Lonza, the contract development and manufacturing giant.

Lonza is paying about $107 million (€100 million) in cash to acquire Synaffix, with up to $64 million (€60 million) in “additional performance-based consideration” on the table. Synaffix’s ADC tech platform will now become part of Lonza’s offering for biopharma clients, lending its bioconjugate technologies to not just ADCs but also targeted gene therapy, immune cell engagers and other applications.

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Richard Pazdur, FDA's OCE director (Flatiron Health via YouTube)

FDA's can­cer chief weighs in on com­mon chemo short­ages — re­port

Richard Pazdur, director of the FDA’s Oncology Center of Excellence, attributes the current shortage of two cancer drugs to drug companies that haven’t invested in building out their production capacity.

In an interview with The Cancer Letter, a weekly cancer publication, Pazdur said that the current shortages of cisplatin and carboplatin, a pair of drugs used to treat a wide range of cancer patients, are the result of two problems: manufacturers not investing in enhancing production capacity, and drug companies being dependent on one supplier of raw ingredients. The cisplatin shortage followed an inspection that revealed quality issues at a manufacturing facility, which then led to the shutdown of production. This led to a surge in carboplatin demand, creating a secondary shortage.

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Photo: Ida Marie Odgaard/Ritzau Scanpix/Sipa USA/Sipa via AP Images

FDA warns about com­pound­ed semaglu­tide-based drugs

The FDA has warned the public that compounded versions of popular GLP-1 drugs Ozempic and Wegovy may not include the same ingredients as the prescription medications, and that has raised questions about their safety and effectiveness.

The regulator said Tuesday it has received reports of adverse events related to compounded versions of semaglutide, the active ingredient in Ozempic and Wegovy. Some products being marketed as semaglutide contain the salt formation of semaglutide, which is not considered safe or effective.

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Eu­ro­pean Par­lia­ment calls mem­ber states to ac­tion on an­timi­cro­bial re­sis­tance

Members of the European Parliament have called on EU countries to develop national action plans against antimicrobial resistance (AMR), calling it a top-three priority health threat.

Parliament on Thursday announced recommendations for the fight against AMR, including national action plans that must be updated at least every two years, an EU-level database tracking AMR and antimicrobial use and increased partnership between the pharma industry, patient groups and academia.

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Man­u­fac­tur­ing roundup: Astel­las to sell Dutch fa­cil­i­ty to Del­pharm; Au­ri­gene in­vest­ing $40M in­to In­dia man­u­fac­tur­ing fa­cil­i­ty

Astellas Pharma is selling its manufacturing plant in Meppel, the Netherlands, to contract manufacturer Delpharm.

Astellas said last week it’s transferring the facility to Delpharm as part of a wider shift for the pharma’s technology and manufacturing business. As part of the deal, for which financial details were not disclosed, Delpharm plans to continue to produce the products that are made in the Meppel plant for Astellas. The employees at the site will also transfer to Delpharm as well. The deal is expected to close by the end of the year.

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Andrey Zarur, GreenLight Biosciences CEO

Green­Light Bio­sciences se­cures merg­er as it looks to go pri­vate

GreenLight Bioscience, the developer and manufacturer of RNA vaccines and therapeutics, is set to be acquired.

The company announced earlier this week that it would be acquired by a group of buyers led by Fall Line Capital in a cash deal valuing GreenLight at around $45.5 million. According to a release, Fall Line and the group agreed to acquire all of the shares of the company for $0.30 per share. The deal is expected to close sometime in the third quarter of this year.

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Roger Perlmutter, Eikon Therapeutics CEO

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

Eikon Therapeutics announced three business development deals on Thursday, effectively dropping in a pipeline of cancer drugs alongside more than $100 million in fresh funding.

The Hayward, CA-based company has become one of biotech’s richest startups since its 2019 founding, having raised nearly $775 million. It’s developing a massive, automated research approach built around Nobel Prize-winning microscope science to peer inside cells and watch proteins in action. After its Series B last year, PitchBook reported a $3.02 billion valuation. And while CEO Roger Perlmutter declined to comment on that figure, he said its first tranche of nearly $106 million in Series C funding is a “meaningful step-up to our Series B valuation.”

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