Salim Haffar, PCI Pharma CEO

PCI fur­ther ex­pands in­to New Eng­land with fill-fin­ish up­grade in New Hamp­shire

A Philadel­phia-based CD­MO will drop $100 mil­lion in­to its asep­tic liq­uid fill-fin­ish and ster­ile lyophiliza­tion tech­nol­o­gy at its re­cent­ly-ac­quired Bed­ford, NH cam­pus.

PCI Phar­ma bought the Lyophiliza­tion Ser­vices of that New Eng­land site at the end of 2021. The new ex­pan­sion will add a 50,000 square-foot fa­cil­i­ty that fea­tures a fill-fin­ish line with a ful­ly iso­lat­ed con­tain­ment sys­tem. It will have the ca­pac­i­ty to fill 400 vials per minute, which will help PCI up its speed and get ther­a­pies to pa­tients quick­er.

The an­nounce­ment is the lat­est in a string of moves across the world. It has ex­pand­ed lo­ca­tions in Rock­ford, IL; San Diego; Mel­bourne, Aus­tralia and Berlin in re­cent years. The com­pa­ny will al­so in­crease ca­pac­i­ty at sites in Spain and Wis­con­sin soon, the press re­lease said.

“We are ex­cit­ed to in­tro­duce clients to our newest fa­cil­i­ty, which is part of our broad­er strat­e­gy to pro­vide in­te­grat­ed end-to-end drug de­vel­op­ment, man­u­fac­tur­ing and pack­ag­ing ca­pa­bil­i­ties,” CEO Sal­im Haf­far said in a state­ment. “Our in­vest­ment in these fa­cil­i­ties will en­sure that PCI con­tin­ues to lever­age new ca­pa­bil­i­ties in com­plex for­mu­la­tions, asep­tic fill-fin­ish, and lyophiliza­tion to meet the needs of our glob­al clients, par­tic­u­lar­ly as bi­o­log­ics con­tin­ue their strong growth tra­jec­to­ry.”

Just in No­vem­ber 2021, PCI an­nounced the con­struc­tion of a new clin­i­cal cen­ter of ex­cel­lence in Bridge­wa­ter, MA, just 25 miles south of Boston. The in­vest­ment al­lows for PCI to be clos­er to clients in the tri-state area, as well as just down the high­way from some of the biggest phar­mas in the world. That cen­ter is sched­uled to be com­plet­ed this sum­mer, and will al­so add 50,000 square feet of op­er­at­ing space to its ar­se­nal.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Sanofi, GSK, Ha­le­on see stock prices dip and dive amid lit­i­ga­tion for re­called heart­burn drug

Zantac became one of the most well-known drugs on the market after being FDA-approved in 1983 — and now close to four decades later, lawsuits over safety concerns are rattling analysts and investors.

Sanofi, GSK and Haleon, GSK’s former consumer healthcare unit, have lost billions of dollars in market cap since Tuesday’s market close, according to Bloomberg. While Zantac is no longer on the market, the drop came after a suite of analysts, from Morgan Stanley and other firms, sounded the alarm on the potential impact of ongoing personal injury litigation.

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