A North­ern Irish con­tract man­u­fac­tur­er is mak­ing some big moves in the Key­stone State.

The Al­mac Group, a glob­al con­tract­ing and man­u­fac­tur­ing com­pa­ny for APIs and phar­ma­ceu­ti­cals is ex­pand­ing its North Amer­i­can head­quar­ters in the town of Soud­er­ton, PA, north­west of Philadel­phia.

The com­pa­ny is look­ing to in­vest $65 mil­lion in­to the fa­cil­i­ty with the plan be­ing to in­crease the clin­i­cal ca­pac­i­ty at the fa­cil­i­ty by 60%. Al­mac is al­so look­ing to add ad­di­tion­al cold and ul­tra-low stor­age as well as just-in-time pro­cess­ing ca­pa­bil­i­ties which Al­mac pre­dicts will be to sup­port the in­dus­try trend to­ward bi­o­log­ics and ad­vanced ther­a­peu­tic med­i­c­i­nal prod­ucts (ATMPs).

The Soud­er­ton ex­pan­sion is ex­pect­ed to break ground some­time in ear­ly 2023, and once com­plete it will bring the com­pa­ny’s North Amer­i­can head­quar­ters to a to­tal of 340,000 square feet.

“Drug de­vel­op­ment and clin­i­cal tri­als con­tin­ue to evolve across the world, with spon­sors ex­pand­ing their pipelines to fo­cus on bi­o­log­ics, vac­cines and ad­vanced ther­a­py med­i­c­i­nal prod­ucts. Al­mac is at the fore­front of build­ing sup­ply chain ex­per­tise and ca­pac­i­ty for this evo­lu­tion,” said Robert Dun­lop, pres­i­dent of Al­mac Clin­i­cal Ser­vices said in a state­ment.

How­ev­er, this is not the on­ly in­vest­ment that Al­mac is look­ing to make. The com­pa­ny is al­so up­grad­ing its two oth­er Mont­gomery Coun­ty sites bring­ing the com­pa­ny’s to­tal in­vest­ment in Penn­syl­va­nia to $93.5 mil­lion. The com­pa­ny is al­so look­ing to add 355 jobs to the state over the next three years.

How­ev­er, to tack­le this ex­pan­sion the com­pa­ny has re­ceived mon­e­tary help from the state. The com­pa­ny re­ceived a fund­ing pro­pos­al from the Penn­syl­va­nia De­part­ment of Com­mu­ni­ty and Eco­nom­ic De­vel­op­ment of $1.8 mil­lion as well as a Penn­syl­va­nia First grant and a $250,000 work­force de­vel­op­ment grant. The com­pa­ny has al­so been en­cour­aged to ap­ply for a man­u­fac­tur­ing tax cred­it and a re­search and de­vel­op­ment tax cred­it pro­gram.

This is not the first ma­jor in­vest­ment the com­pa­ny has made in Penn­syl­va­nia. In 2016, the com­pa­ny com­mit­ted to leas­ing out 26,000 square feet of of­fice space in Lans­dale, PA, and in­vest­ing around $24.4 mil­lion in an ex­pan­sion project that saw the com­pa­ny add more ma­chine lines and cold stor­age as well as cre­ate 312 jobs.

While the Key­stone state is cer­tain­ly on the com­pa­ny’s mind, it has not ne­glect­ed its home in North­ern Ire­land, where last year it an­nounced that it was ex­pand­ing its Ar­magh lo­ca­tion by 42,000 square feet.

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

James Sabry’s BD team at Roche has a long track record in hunting the globe for new biotech deals. But they’ve never journeyed into China before to ink a worldwide development and commercialization pact with a China-based biotech on an experimental med.

As Max Gelman reported yesterday, Roche fronted a new alliance with China’s Jemincare with $60 million in cash and $590 million in milestones for worldwide commercial rights to an oral androgen receptor degrader. The deal itself is fairly typical of an early-stage alliance around a promising treatment. The Shanghai-based biotech is largely unknown outside China, but this is a classic high-risk, modest upfront pact that Roche routinely inks.

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Martin Landray knows what controversy in clinical drug development feels like, from first-hand experience.

Landray was the chief architect of RECOVERY, a study that pitted a variety of drugs against Covid-19. And he offered some landmark data that would help push dexamethasone out into broader use as a cheap treatment, while helping ice hydroxy’s reputation as a clear misfire.

“Lots of people told us we shouldn’t use it,” Landray says about dexamethasone and Covid-19. “It was dangerous. We shouldn’t even do a trial. They also cared about hydroxychloroquine and lots of people said we shouldn’t do a trial because it must be used. I’ve got the letters from both sets of people.”

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Roche’s Genentech is going high style next month for New York Fashion Week. The pharma is hosting its first-ever runway fashion show to raise disability visibility, featuring models from the spinal muscular atrophy (SMA) community.

“Double Take” will be held Sept. 8, the day before the official New York event begins, with models walking and rolling across the stage wearing stylish and functional adaptive clothing. Eleven people living with SMA and four advocates will show off the custom fashions created by Open Style Lab, a Brooklyn nonprofit and accessible clothing design collaborative.

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It’s been just two days since Endo International filed for bankruptcy in an attempt to dig itself out of thousands of opioid lawsuits. Now one of its top sellers is in trouble.

A federal appeals court on Thursday affirmed a Delaware judge’s decision that Eagle Pharmaceuticals’ generic version of Endo’s vasopressin injection Vasostrict does not infringe on the company’s patents. Eagle’s version won approval back in December, and already, the generic and others like it have driven down Vasostrict sales.

After a nearly 365-day delay, Axsome Therapeutics has secured its first drug approval with an FDA green light for Auvelity as a treatment for adults with major depressive disorder.

The biotech is keeping shy on the pricing for now and, on an investor call, CEO Herriot Tabuteau attributed the FDA’s yearlong delay mainly to the Covid-19 pandemic. The rapid-acting NMDA receptor antagonist is not a scheduled drug under the DEA, the CEO confirmed on the call.

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Two drug manufacturers on opposite sides of the globe are facing the heat from the FDA over several quality control issues.

India-based manufacturer Sun Pharma was hit with a Form 483 following an FDA inspection of its Mohali facility from Aug. 3-12.

The FDA found failures when reviewing unexplained discrepancies regarding whether a batch already had been distributed at the location.

The investigation found that there were instances of backdating, but Sun’s report was not thorough enough for the FDA to evaluate the full scope of the offense. Sun did not interview all quality assurance reviewers, but it did confirm backdating by employees who had denied the practice initially. Sun also did not have a thorough review of other work performed by the employees, according to the FDA report.

José Romero is a Latino HIV activist in Durham, North Carolina — and one of the stars of Gilead Sciences’ docuseries about the impact of HIV in the South.

The six-part “Blind Angels” series initially aired on CNN over the past few months with individual episodes now being submitted and screened at film festivals around the country. Romero’s episode, for instance, was screened at the OutSouth Queer Film Festival in Raleigh-Durham last weekend. Romero spoke at the festival and to a “standing room only” audience, a Gilead spokesperson said.

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You win some, you lose some. And in New Jersey federal court on Wednesday, Bausch Health won.

About a month after a Delaware court found certain Xifaxan patents invalid — potentially opening the door for generic competition — a New Jersey court sided with Bausch in a separate patent feud with Curia.

Curia filed suit against Bausch’s Salix back in 2021, claiming the antibiotic Xifaxan infringed on four patents filed in 2013 and 2014 for certain ratios of the α and β polymorphic forms of the active ingredient rifaximin. However, Bausch argued that Xifaxan was marketed in the US before the patents were filed — its 200 mg dose has been sold since 2004 and its 550 mg since 2010 — and therefore should be regarded as “prior art.”

Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

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