Gilead is adding it­self to the list of big names build­ing out mul­ti­mil­lion-dol­lar ex­pan­sions in Ire­land.

The phar­ma is ex­pand­ing its fa­cil­i­ties lo­cat­ed in the town of Car­rigt­wohill, Ire­land, in Coun­ty Cork in the south of the coun­try. Gilead plans to sink €45 mil­lion ($47.5 mil­lion) in­to the ex­pan­sion which will be used to con­struct a 55,714-square-foot ware­house, ac­cord­ing to a state­ment emailed to End­points News. The in­vest­ment will re­sult in a small in­crease in its em­ploy­ee head­count in Cork, a Gilead spokesper­son said, but no oth­er de­tails were giv­en be­yond that.

The spokesper­son said:

Gilead’s op­er­a­tions in Ire­land are a crit­i­cal part of its glob­al sup­ply chain. This de­vel­op­ment will fa­cil­i­tate ad­di­tion­al fu­ture in­vest­ment in the com­pa­ny’s man­u­fac­tur­ing and pack­ag­ing ca­pa­bil­i­ties in the coun­try, as the site looks to sup­port an ex­pand­ed Gilead prod­uct port­fo­lio in the years ahead.

As re­port­ed by The Irish Times, Gilead aims to start con­struc­tion in April and ex­pects to be fin­ished by No­vem­ber of next year. The ware­house will pro­vide stor­age for both fin­ished prod­ucts and raw ma­te­ri­als.

The 366,000-square-foot man­u­fac­tur­ing site in Cork is re­spon­si­ble for 30% of all of Gilead’s sol­id oral drug de­vel­op­ment, with 24 of its prod­ucts be­ing pro­duced or pack­aged at Car­rigt­wohill. The site, ac­cord­ing to Gilead’s web­site, is al­so re­spon­si­ble for pro­duc­tion, qual­i­ty con­trol and pack­ag­ing for the dis­tri­b­u­tion of its prod­ucts to the EU and oth­er spots in­ter­na­tion­al­ly.

Gilead is al­ready in good com­pa­ny in Car­rigt­wohill, as sev­er­al ma­jor phar­mas have man­u­fac­tur­ing sites in the town and al­so have plans to ex­pand.

The Ger­man drug man­u­fac­tur­er Mer­ck KGaA is in­vest­ing ap­prox­i­mate­ly €290 mil­lion ($306.1 mil­lion) to in­crease its mem­brane man­u­fac­tur­ing ca­pac­i­ty in Car­rigt­wohill and sup­port its gene ther­a­py man­u­fac­tur­ing ca­pa­bil­i­ties. The lat­est plan comes on top of a €36 mil­lion ($38 mil­lion) in­vest­ment in 2021 for an­oth­er pro­duc­tion line at its fa­cil­i­ty.

Ab­b­Vie is al­so in­ject­ing €60 mil­lion ($63.3 mil­lion) in­to its man­u­fac­tur­ing site in Car­rigt­wohill and plans to boost its head­count by 70, but oth­er de­tails were not avail­able.

Adaptimmune is merging with TCR² Therapeutics in a bid to create a T cell therapy developer aimed at solid tumors.

The all-stock deal brings together both companies’ lead candidates — Adaptimmune’s afami-cel, which targets MAGE-A4, and TCR²’s mesothelin-targeting gavo-cel — as well as a pipeline of candidates engineered with T cell receptors, or TCRs. Unlike CAR-T therapies, TCR-T is not limited to surface antigens but can target antigens inside cancer cells.

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When Hannah Sames was 4 years old, she was diagnosed with an ultra-rare genetic condition called giant axonal neuropathy. She’s 18 now, and her doctors expected long ago that she would be quadriplegic, and consigned to an early death.

Instead, she can stand, albeit with help. “Even with her physical challenges, she’s happy. She’s a typical teenager who is social and loves music,” said her mother, Lori Sames.

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Moderna has decided on the green fields of Oxfordshire to build its newest research and manufacturing site.

Moderna plans to open the site, called the Moderna Innovation and Technology Center (MITC), on the Harwell Science and Innovation Campus, which sits near the village of Harwell, UK, 16 miles south of the city of Oxford. The MITC will have both research and development capabilities and a manufacturing facility, Moderna said in a release sent to Endpoints News.

Luxembourg-based Covis Pharma has been in a tug of war with the FDA over whether to pull its controversial preterm birth drug Makena, which won an accelerated approval in 2011 but failed its confirmatory trial in 2018.

After two failed adcomms, Covis is now waving the white flag and agreeing to pull the drug from the market, according to documents posted this afternoon.

The decision from Covis follows a 14-1 vote from the FDA’s Obstetrics, Reproductive and Urologic Drugs Advisory Committee last October to pull the drug, which failed to confirm the drug’s benefit for babies or mothers.

Take a look at the 53 inhalers approved by the FDA to treat asthma and COPD from 1986 to 2020, and you will find generic versions for just four of those brand-name products, and a widening gap where manufacturers may be hesitant to jump in, researchers from Georgetown, the University of Calgary, University of West Virginia and Harvard wrote in a Health Affairs article published yesterday.

That dearth of competition has meant decades of monopolies for blockbuster inhalers dispensing common asthma, COPD and other treatments like albuterol, budesonide formoterol, and fluticasone-salmeterol. But there has been a slight uptick in progress recently as they note:

AbbVie execs touted a wave of Rinvoq programs at Cowen’s annual conference on healthcare Tuesday as they brace for a tougher Humira battle in the second half of this year.

Since its first approval in rheumatoid arthritis in 2002, Humira became one of industry’s top sellers ever, adding a wide list of indications from ulcerative colitis to ankylosing spondylitis. The first biosimilar to Humira, Amgen’s Amjevita, launched at the end of January, and AbbVie execs announced on the last quarterly call that they expect a 37% drop in Humira sales this year.

South by Southwest, abbreviated SXSW and also simply called South By, has a decades-long image of cutting-edge culture and hipster mingling. So what are pharma companies and healthcare agencies doing there? Fitting in, actually.

No longer just for music and film fans or digital and technology futurists, today’s SXSW runs a gamut of industries and topic tracks, and that includes health-focused ones. While the main SXSW Health and Medtech track isn’t brand new, its relevance for pharma marketers is growing.

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Genentech is amplifying its commitment — and increasing its pledges — to counter systemic racism in healthcare and education. The Roche company and its Genentech Foundation recently committed $17 million to 31 grantees, a 40% increase over its last round of $12 million in funding pledges in 2022.

It’s also prioritized diverse and representative teams, with 94% of the grantee groups led or co-led by people of color. That’s up from 70% last year.

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J&J and biotech partner Protagonist Therapeutics claimed a Phase IIb win in plaque psoriasis Tuesday morning. But near-term plans for the drug remain murky.

The study, looking at an oral IL-23 drug called JNJ-2113, hit its primary endpoint in adults with moderate-to-severe plaque psoriasis, the companies said. Researchers saw more patients who took the drug achieve PASI-75, or at least 75% improvement in skin lesions, by a statistically significant margin compared to placebo in all five treatment cohorts.

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

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