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Pfizer taps Samsung Biologics in long-term biosimilar production deal worth $411M

South Korea’s Samsung Biologics has captured a $411 million contract to manufacture biosimilars for pharma giant Pfizer.Under the deal, Samsung has pledged “additional capacity for large-scale manufacturing for a multi-product biosimilars portfolio covering oncology, inflammation, and immunology.” The company described the deal as a “long-term” arrangement. Pfizer’s biosimilar portfolio features copycats to Roche’s cancer trio of Rituxan, Avastin and Herceptin plus biosimilar versions of Johnson & Johnson’s Remicade and Amgen’s Neupogen. The Samsung partnership will likely also include production of Pfizer’s biosimilar to AbbVie’s Humira, The Korea Herald reports, citing industry experts. AbbVie recorded $21.24 billion in sales of Humira last year. Amgen is already marketing a Humira copycat, but Pfizer and many other players are set to enter the market this year. In a financial filing, Samsung Biologics put the value of the Pfizer deal at $411 million, making it the biggest of its nature for the company and ...
- Source: drugdu
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- June 11, 2023
After nationwide deal, Teva reaches $193M opioid settlement with holdout Nevada

When Teva proposed its sweeping $4.25 billion opioid settlement to resolve thousands of claims across the country, all U.S. states except for Nevada and New Mexico jumped on board. Now, the company has worked out a separate $193 million deal with one of the holdouts.Under the deal, the generics giant will make annual payments to Nevada on a sliding scale starting next July and lasting through July 2043. The payouts will start at $7 million and rise to $9 million through 2037, then increase to $27 million in 2042. The cash will be divvied between Nevada and members of the One Nevada Agreement on Allocation of Opioid Recoveries, a group formed to distribute opioid-related funds to local governments. The deal also includes injunctive relief to put a stop to opioid misuse in the state. For one example, Teva is required to halt the promotion of opioid products, according to a ...
- Source: drugdu
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- June 11, 2023
AstraZeneca to stop post-marketing study of Andexxa following early success

AstraZeneca (AZ) has announced that it will stop its post-marketing study of bleeding reversal agent Andexxa (andexanet alfa) after the trial met its primary endpoint earlier than planned. The phase 4 ANNEXA-I study has been assessing the safety and efficacy of the drug versus standard care in more than 450 patients experiencing an intracranial haemorrhage who have received oral Factor Xa-inhibitor treatment, including apixaban and rivaroxaban. Results from a planned interim analysis of the trial showed that Andexxa-treated patients experienced superior haemostatic efficacy – the ability to limit the expansion of a potentially life-threatening bleed in the brain – compared with the control arm, leading the data monitoring board to recommend that the study be ended. Millions of people worldwide depend on Factor Xa inhibitors to manage their risk of blood clots developing, but these medicines carry a small but significant risk of an acute major bleed. AZ reports that ...
- Source: drugdu
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- June 11, 2023
Oura launches new social, sleep features as health tracker market continues to grow

Oura, the company behind the smart ring that allows users to track a variety of biometric data, is adding new features around social sharing and sleep tracking as the battle among tech companies to land and keep trackers on the wrists and fingers of consumers continues. The company’s new community-sharing feature, which it calls Circles, allows ring wearers to create private groups where they can share readiness, sleep, and activity scores. Oura CEO Tom Hale said that the feature is not about competition like other more fitness-focused tracking devices or platforms might offer, but instead it’s about “support and empathy.” “It’s really about sharing your data, your scores, your readiness, your sleep, with your close, intimate friends, family, your trainer, your doctor; maybe it’s a husband checking in on a wife or maybe it’s your team collecting the data comparing each other,” Hale said to CNBC’s Andrew Ross Sorkin on ...
- Source: drugdu
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- June 11, 2023
Uncovering cancer-immune system interactions could inform how patients respond to immunotherapy

Researchers at the Francis Crick Institute and King’s College London have revealed the complex interactions between cancer and the immune cells that surround a tumor, with the potential to inform how patients will respond to immunotherapy.In the study, published in the journal Genome Medicine, the researchers analyzed thousands of samples across 32 types of cancer to examine the way that cancer dynamically interacts with the tumor immune microenvironment (TIME), allowing the disease to flourish. Cancer evolves within the TIME, which is sculpted by cancer cells and, in turn, sculpts the cancer genome. These dynamic interactions have a significant impact on how the cancer develops and responds to treatments such as immunotherapy. Gaining a greater understanding of cancer-immune system interaction is therefore crucial to understanding cancer biology. The researchers focused on a class of genes called cancer drivers because, when altered, they help drive cancer. They identified 477 of these cancer ...
- Source: drugdu
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- June 11, 2023
Study reveals first genetic locus for voice pitch

In a paper published in Science Advances, an international team led by deCODE genetics, a subsidiary of Amgen, reveals the discovery of sequence variants in the gene ABCC9 that influence the pitch of voices. Speaking is one of the most characteristic human behaviors, and yet the genetic underpinnings of voice and speech are largely unknown. In the first study of its kind, the scientists combined speech recordings from almost 13,000 Icelanders with data, in the sequence of the genome, to search for common variants in ABCC9 that are associated with a higher-pitched voice. The scientists found that ABCC9 variants associate with higher voice pitch in both men and women. The same sequence variants are also linked to higher pulse pressure, a cardiovascular risk factor, highlighting links between voice pitch and health-related traits. In addition to voice pitch, the study investigated the genetics of vowel acoustics. While vowel sounds such as ...
- Source: drugdu
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- June 11, 2023
Sanofi, AstraZeneca’s RSV antibody for infants easily clears FDA adcomm, likely setting up approval

Seeking to launch their respiratory syncytial virus (RSV) prevention antibody for infants later this year, Sanofi and AstraZeneca have cleared one more regulatory hurdle.Thursday, experts on the FDA’s Antimicrobial Drugs Advisory Committee voted 21 to 0 that nirsevimab boasts a favorable benefit-risk profile to protect against RSV-associated lower respiratory disease in infants born during or entering their first RSV season. On a separate question of whether the drug has a favorable benefit-risk profile in children up to 24 months of age who remain vulnerable through their second RSV season, the vote was 19 to 2 in favor of the drug. “Most babies hospitalized with RSV are born at term and healthy, which is why interventions specifically designed to protect all infants are likely to result in the greatest impact,” Sanofi’s executive vice president of vaccines, Thomas Triomphe, said in a Thursday statement. “We are encouraged by the Advisory Committee’s positive ...
- Source: drugdu
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- June 10, 2023
’ Seagen CEO talks about his next stop, Pfizer deal and the ADC landscape

David Epstein’s short tenure as Seagen’s CEO will likely end soon with the antibody-drug conjugate specialist’s sale to Pfizer. After a rich career spanning companies of various sizes, Epstein is keeping an open mind about where he might head next.“I will hopefully make new drugs somewhere else,” Epstein said in a recent interview on the sidelines of the American Society of Clinical Oncology’s annual meeting. “I don’t know where that will be.” Throughout his time in biopharma, Epstein has worn many hats. He’s known for building Novartis’ oncology unit and leading the Swiss giant’s larger global pharma business. He fostered startups for five years at Flagship Pioneering before taking the reins at Seagen in November. Those roles have given him experience in almost every therapeutic area and in both drug development and commercialization. That kind of resume opens a lot of possibilities—although going back to Flagship isn’t his plan right ...
- Source: drugdu
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- June 10, 2023
Axol and StrataStem link up for Alzheimer’s disease trial

Companies will incorporate cells and technology to create a ‘clinical trial in a dish’ Axol Bioscience – a stem cell technology provider – has reached an agreement with StrataStem to access and commercialise its collection of Alzheimer’s disease (AD) patient samples. Under the terms, Axol will reprogramme the samples into ‘induced pluripotent stem cells’ (iPSCs) that can subsequently be separated into an extensive range of brain cells. These include neurons and neuroinflammatory cells. Formed in vitro, the cells can provide patient-specific human brain models from a cohort of AD patients, ultimately creating a ‘clinical trial in a dish’. The research concentrates on sporadic AD (sAD) – the most prevalent form of the disease, accounting for over 95% of all cases. sAD has no specific family link and is triggered by a combination of genetics, the environment and an individual’s lifestyle. Meanwhile, StrataStem’s collection of donor materials, including blood samples and ...
- Source: drugdu
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- June 10, 2023
Janssen shares positive phase 3 results for erdafitinib in bladder cancer

The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) has shared positive results from a late-stage study of erdafitinib in urothelial carcinoma, the most common type of bladder cancer. Urothelial carcinoma accounts for approximately 90% of bladder cancer cases, and up to 20% of patients diagnosed with metastatic urothelial carcinoma have an FGFR genetic alteration. Despite most urothelial carcinomas being diagnosed at an early stage, rates of recurrence and disease progression are high and a significant proportion of patients who undergo radical surgery will experience disease recurrence. Martin Vogel, EMEA therapeutic area lead oncology, Janssen-Cilag GmbH, said: “Bladder cancer, of which urothelial carcinoma is the most common form, carries a high burden of disease for patients… Patients with advanced urothelial carcinomas, including FGFR-driven tumours who have exhausted standard treatment options, can face a particularly poor prognosis.” Results from an interim analysis of cohort 1 in the phase 3 THOR trial, ...
- Source: drugdu
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- June 10, 2023

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