Outsourcing channel feed

FDA calls for re­peat bioe­quiv­a­lence stud­ies af­ter un­cov­er­ing 'in­valid' da­ta from two In­di­an CROs

After finding “significant instances of misconduct and violations of federal regulations,” leading two Indian CROs to submit “invalid study data to FDA,” the agency is now calling on certain unnamed generic and brand name drug companies to run bioequivalence tests again for some of their marketed products.

The FDA said that after looking into the clinical and bioanalytical studies conducted by Synchron Research Services in Gujarat, India, and Panexcell Clinical Lab in Maharashtra, India following an inspection in late Nov. 2019, data from either company are no longer acceptable to support a determination of safety or effectiveness for brand name drugs, or to show affected generic drugs are bioequivalent to their brand name counterparts.

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Con­tract re­search is hav­ing a mo­ment right now. Will M&A splash­es dri­ve the in­dus­try to even greater heights?

Contract research organizations are a fairly mysterious bunch. They’re typically considered the skilled laborers behind big drug development — the stage crews who run the trials behind some of the most (and least) successful data reveals in biopharma history.

But all that is changing.

This year, a couple of huge, out-of-the-blue M&A deals sounded the alarm on just how much money is flying around in this corner of the industry.

John Kreger, an analyst at William Blair, estimates that about half of all clinical trial work is outsourced to contract research organizations, also known as CROs. In recent years, the companies have slowly begun to take on a new look, with services now ranging from consulting to manufacturing and commercialization. It’s an industry that’s projected to reach $90 billion by 2026, according to Fortune Business Insights. 

“No one has great data about how big this market is or how much is outsourced. Everyone’s dealing with estimates,” Kreger said.

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Catalent CEO John Chiminski

Catal­ent inks deal with Phath­om to make GI drug at re­cent­ly-ren­o­vat­ed Ken­tucky site

Summer’s over, but New Jersey-based CDMO Catalent had time to squeak in one last deal.

Catalent has signed an agreement to commercially manufacture Phathom Pharmaceuticals’ lead drug, vonoprazan, for the treatment of gastrointestinal diseases. If the drug is approved by the FDA, Catalent will manufacture and package the drug at its large-scale oral solid dose site in Winchester, KY. Phathom has the rights to develop and commercialize vonoprazan in the US, Europe and Canada.

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Kent Payne, BioDuro-Sundia

Bio­Duro-Sun­dia plants its flag at for­mer Par man­u­fac­tur­ing site in CA

A former Par Pharma site in Irvine, CA, will now have a new tenant.

BioDuro-Sundia will acquire a 40,000-square-foot oral solid dose manufacturing site in Irvine, the company announced Monday.

The site will allow the company to scale up and cater to companies that need larger-scale production, Kent Payne, the president of development and manufacturing, said in a press release. The new site should be operational by the start of 2022. It will be able to produce 1 billion tablets and capsules a year, the company said.

Lee Jae-yong, president of Samsung Biologics (AP Photo/Ahn Young-joon)

As leader is freed from prison, Sam­sung Bi­o­log­ics nabs mas­sive in­vest­ment from par­ent com­pa­ny's $205B spend­ing spree

One of biotech manufacturing’s giants has announced a massive investment in its operations over the next three years.

Samsung Biologics will receive a share of a $205 billion investment from its parent company, along with Samsung Electronics, as the Korean company ramps up its semiconductor, biopharmaceuticals and telecommunications units. More than $154 billion of that money will be spent right in South Korea, as the company plans to create 40,000 new jobs by 2023. And M&A is very much on the table.

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Ver­i­ly scoops up a fel­low soft­ware mak­er as Amy Aber­nethy scales its clin­i­cal tri­als plat­form

Amy Abernethy now has a whole new set of tools to tap into as she scales up the clinical trial management platform at Verily.

The life sciences outfit — now officially a subsidiary of Alphabet on equal footing with Google — has acquired SignalPath for an undisclosed amount, giving it access to a system of digital solutions that make it easier to run clinical trials, and promise to simultaneously boost quality and efficiency.

Alan Hirzel, Abcam

Ab­cam brings a long­time col­lab­o­ra­tor in house as part of $340M buy­out pact

BioVision has supplied Abcam with research tools since 1999, and now the two are making it official as part of a merger unveiled Monday.

Abcam will buyout BioVision as part of a $340 million acquisition deal to bring aboard the supplier’s biochemical and cell-based assays for biological research, as well as recombinant proteins, antibodies and enzymes.

The deal will give Abcam control of BioVision’s portfolio and allow for both the expansion of research existing areas of focus such as oncology, neuroscience and epigenetics and preparation to expand into new products. As a part of the deal, Abcam will develop and supply products and services to NKY, the previous owner of BioVision and receive support for ongoing development and commercialization of in vitro diagnostic products.

Prahlad Singh, PerkinElmer CEO

Shelling out $5B+, PerkinElmer pays the big bucks for an­ti­body and reagent play­er

PerkinElmer has been busy on the acquisition front throughout the Covid-19 pandemic, and on Monday, the Massachusetts-based diagnostics and life sciences company added the biggest feather to its cap.

PerkinElmer will acquire antibody and reagents provider BioLegend for nearly $5.25 billion, the entities announced Monday morning. The deal is PerkinElmer’s third acquisition since November 2020 as it kicked development of Covid-19 testing into high gear, as well as the company’s biggest buyout ever.

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Re­ci­pharm to con­struct new In­di­an fill-fin­ish fa­cil­i­ty as part of ex­ist­ing re­la­tion­ship with Nichep­harm found­ing fam­i­ly'

India is getting a manufacturing boost that will add the capacity to produce another 1 billion injectables.

Recipharm announced the construction of a new fill-finish facility in Uttarakhand, near Dehradun, in collaboration with the Sobti family. The development is the latest move in a partnership with the family, which began in 2019 after Recipharm invested in Nichepharm.

The site will up Recipharm’s sterile fill-finish service to complement already existing locations in France, Germany and Italy. The project’s next step is to gain authorization from European regulators.

Catal­ent keeps adding on at key Ital­ian plant, this time with a pair of new biore­ac­tors and 100 jobs

For the second time in less than six months, Catalent will upgrade its sleek new facility in Anagni, Italy, this time to add biologics drug substance manufacturing capabilities to support an increase in demand.

Two new 2,000 liter single-use bioreactors with new manufacturing suites will support early-phase clinical development and late-stage commercial transfers, the company said in a press release, as well as space for another six bioreactors to be added in the future. The project is expected to add 100 new employees, and it should be operational in April 2023.