Rahul Singhvi, Resilience CEO (Business Wire)

UP­DAT­ED: ARCH-backed Re­silience nabs its lat­est fi­nanc­ing round, putting to­geth­er a mas­sive $625M Se­ries D

Since emerging from stealth in late 2020, Resilience has methodically built up its cash reserves and inked numerous collaboration deals. On Monday, the company announced its latest move.

The Bob Nelsen-backed biotech revealed plans for its Series D early Monday morning, putting together $625 million to further its mission of becoming the “Foxconn” of biotech. Monday’s new cash will be used to continue investing in its infrastructure through more deals, potential acquisitions and R&D expansion.

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MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

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.

Mathai Mammen (Rob Tannenbaum, Endpoints News at BIO 2018)

Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck five years ago, where the soft-spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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Illustration: Kim Ryu for Endpoints News

Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

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Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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Civi­ca, Mayo Clin­ic and oth­ers sound off on FDA draft guid­ance to mit­i­gate drug short­ages

Several pharma groups are laying out the positives and negatives of new FDA draft guidance on how best to handle drug shortages.

The draft is intended to help companies develop and implement risk management plans (RMPs) to assist with any shortages of drugs or biologics. The guidance recommends a framework and factors for stakeholders to develop RMPs for their establishments, API manufacturers and others.

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HHS Secretary Xavier Becerra (Patrick Semansky/AP Images)

US weighs new route of ad­min­is­tra­tion for mon­key­pox vac­cine as cas­es climb — re­port

Less than a week after HHS Secretary Xavier Becerra declared monkeypox a national health emergency, reports have emerged that the US plans to extend its vaccine supply by opting for a different route of administration.

Officials are expected to call for intradermal injection of Bavarian Nordic’s Jynneos vaccine — the only shot approved specifically for monkeypox in the US — as opposed to subcutaneous injection, unnamed sources told both the New York Times and Washington Post on Tuesday.

To avoid short­age of Mer­ck­'s di­a­betes drug, FDA al­lows high­er im­pu­ri­ty lev­els tem­porar­i­ly

The FDA said Tuesday that it recently became aware of a nitrosamine impurity, Nitroso-STG-19 or NTTP, in certain samples of Merck’s type 2 diabetes drug Januvia.

To avoid a shortage of the drug that pulled in more than $10.5 billion for Merck in 2020 and 2021, and to help ensure patients have access to an adequate supply, the FDA said it will not object to the temporary distribution of sitagliptin containing the impurity above the acceptable intake limit.

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Work­ers at Pfiz­er Aus­tralian man­u­fac­tur­ing site the lat­est to walk out in la­bor dis­pute protests

Pharma companies have been no stranger to labor disputes recently and the latest one is hitting a Pfizer manufacturing site in the land down under.

According to the United Workers Union (UWU), employees at Pfizer’s pharmaceutical manufacturing plant in the Perth suburb of Bentley have walked off for 24 hours in protest of what the union sees as a substandard pay offer for workers.

Union members said Pfizer refused to consider a wage increase in line with the cost of living. Pfizer has reportedly offered a 12% increase in wages over three years, while union members are pursuing 18%.

'Messy at best': Is the US re­peat­ing the same Covid mis­steps with mon­key­pox mes­sag­ing?

When Kyle Planck first suspected he might have monkeypox in late June, he went to the CDC website and found six photos of different types of lesions. And that was about it for general public information.

Planck, who is a sixth-year PhD pharmacology researcher at Weill Cornell, kept looking though and found a separate part of the CDC website meant for healthcare professionals. There he found a medical slide deck with more pictures, professional journal articles and more details about symptoms and diagnosis.

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