PharmaFocus Today – Page 330 – media

Biogen Makes Changes to Board of Directors Ahead of Annual Shareholder Meeting

By Tristan Manalac Pictured: A Biogen building/courtesy of PictureDesignSwiss/shutterstock Biogen announced Monday that three of its directors—Alexander Denner, William Jones and Richard Mulligan—will not stand for re-election at the company’s annual stockholder meeting Wednesday. Instead, Susan Langer will be up for election to Biogen’s board of directors. This latest shake-up comes after board chair Stelios Papadopoulos announced he was stepping down from his post after the annual meeting. Papadopoulos will be succeeded by Caroline Dorsa, a long-standing member of Biogen’s board who had previously served for more than two decades at Merck. Meanwhile, Langer is currently serving as president of Souffle Therapeutics, a privately held start-up that has most recently scored $50 million in investments, according to PitchBook. Before that, Langer was also the founding president of Kojin Therapeutics and the founding chief business officer of Paratus Sciences. She also previously worked at Biogen in posts of increasing responsibility. Endpoints ...
- Source: drugdu
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Bayer needs ‘midsize acquisition’ to reach $10B oncology sales goal, exec says

Bayer recently laid out its ambition to achieve $10 billion in sales from its oncology business by 2030 and become a top 10 cancer drug player. To get there, the company is looking outside for a “midsize acquisition,” Bayer’s oncology chief Christine Roth said.Right now, Bayer’s Nubeqa leads the charge in the company’s oncology department, with its sales projected to peak at more than 3 billion euros. In addition, the company’s acquisitions of Vividion Therapeutics, BlueRock Therapeutics and Noria Therapeutics in recent years have bolstered its research capabilities. “We’ve done a lot of activity to fill our early pipeline,” Roth said in an interview with Fierce Pharma on the sidelines of the American Society of Clinical Oncology’s 2023 annual meeting. “But if we want to achieve that top 10 spot in the next four to six years, it’s going to take the right midsize acquisition to get there.” Roth agreed ...
- Source: drugdu
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With Iveric Bio buyout, Astellas CEO Naoki Okamura acted on the company’s mantra to be ‘aggressive’

Earlier this year, when Astellas announced that Naoki Okamura was taking over as CEO, the Japanese company said that 2023 was the right time for it to “go on the aggressive to further stimulate growth.”It took Okamura less than a month into his tenure—which began April 1—to act on the company’s game plan. On April 29, he struck the largest acquisition in Astellas’ history, a $5.9 billion buyout of Iveric Bio. With the New Jersey-based biotech two months away from an FDA decision on its geographic atrophy (GA) eye disease candidate Zimura, Astellas hopes to become a major player in a new arena. “We had been closely watching the lead program for Iveric for a very long time, probably seven, eight years,” Okamura said in an interview with Fierce Pharma. “Because the modality of that project is very new to us, we were kind of hesitant to do any partnerships ...
- Source: drugdu
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- June 15, 2023
Amgen, Horizon blast FTC’s ‘baseless assumptions’ in response to antitrust lawsuit

As Amgen and Horizon pursue their $27.8 billion merger, they’re facing off against the U.S. Federal Trade Commission and its lawsuit to block the deal. Now, in response to the complaint, the companies have called the lawsuit “as misguided as it is unprecedented.”The lawsuit, filed in May, seeks an injunction against the deal on antitrust grounds. Specially, the FTC argued that Amgen could pressure insurers and pharmacy benefit managers to accept higher prices for Horizon’s thyroid eye disease drug Tepezza and gout med Krystexxa based on the company’s “history of leveraging its broad portfolio of blockbuster drugs to gain advantages over potential rivals.” Amgen and Horizon find these allegations “far too speculative” to make the case of probable harm, the two companies said in their response, filed Friday in federal court. The FTC expects Amgen to bundle its rebates in the event of future competition to Horizon’s products, which the ...
- Source: drugdu
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After Albireo buyout, Ipsen’s Bylvay picks up new FDA-approved use

After Ipsen made a splash at this year’s J.P. Morgan Healthcare Conference by scooping up liver disease specialist Albireo Pharma, the centerpiece of the buyout, Bylvay, has won a coveted label expansion.First approved by the FDA to treat cholestatic pruritus from progressive familial intrahepatic cholestasis, Bylvay has now won an FDA approval in another liver disease. Specifically, the drug can now treat cholestatic pruritus due to Alagille syndrome in patients 12 months of age and older. Cholestatic pruritus is the intense itching that afflicts patients with the diseases. A once-daily ileal bile acid transport inhibitor (IBATi), Bylvay will challenge Mirum Pharmaceuticals’ Livmarli in this disease. Livmarli won an FDA approval in Allagile syndrome back in 2021 and generated $29 million during the first quarter of 2023. Analysts with Evercore ISI have previously put a $1 billion peak sales target on Mirum’s rival drug. Bylvay’s new approval is based on results ...
- Source: drugdu
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GSK Awaits Approval for Myelofibrosis Hopeful

The FDA’s final action date this week is for GSK’s investigational drug, momelotinib, which the company is proposing to treat myelofibrosis patients with anemia. The decision is set to be released by June 16. According to GSK, momelotinib works through a differentiated mechanism of action that involves the inhibition of three signaling pathways: the JAK1 and JAK2 cascades, as well as the activin receptor type I (ACVR1) pathway. By disrupting JAK1 and JAK2 signaling, momelotinib induces improvements in patient constitution and symptoms of splenomegaly. Meanwhile, its ACVR1 activity could decrease levels of hepcidin, which contribute to anemia in myelofibrosis. Data from the pivotal Phase III MOMENTUM trial supported momelotinib’s FDA bid. In December 2022, GSK reported 48-week results from MOMENTUM at the 64th American Society of Hematology (ASH) Annual Meeting. Momelotinib achieved its primary efficacy endpoint of an at-least 50% reduction in Total Symptom Score after 24 weeks. GSK’s myelofibrosis ...
- Source: drugdu
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- June 14, 2023
BMS Seeks Another Indication for Camzyos

The FDA will release its verdict on June 16 regarding Bristol Myers Squibb‘s sNDA proposing to use its heart drug Camzyos (mavacamten) to lower the need for septal reduction therapy (SRT) in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). Currently, many patients suffering from HCM need to undergo SRT, Roland Chen, senior vice president and head of cardiovascular development, Global Drug Development at BMS, said in a statement upon the FDA’s acceptance of the sNDA. SRT is either an open-heart surgical procedure or a catheter-based operation. BMS supported Camzyos’ sNDA with data from the Phase III VALOR-HCM study, a randomized, double-blinded and placebo-controlled trial that enrolled 112 patients with symptomatic obstructive HCM. All participants were qualified for SRT and had been referred for the operation. VALOR-HCM’s primary endpoint was a composite between the number of patients who decided to push through with SRT by week 16 and the number of ...
- Source: drugdu
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Thyrotropin-releasing hormone neurons play a key role in the response to fasting and weight loss

Regulation of thyroid hormone (TH) levels is a complex multilevel phenomenon. The paraventricular nucleus (PVN) of the hypothalamus (the region of the brain that controls the involuntary nervous system) has been identified as a direct regulator of thyrotropin (a hormone secreted by the pituitary gland that regulates the production of thyroid hormones). The PVN is a key regulator of TH levels, integrating multiple signaling systems. Now for the first time, researchers from Boston University Chobanian & Avedisian School of Medicine, have shown that in addition to being critical for regulating thyroid hormone levels, thyrotropin-releasing hormone (TRH) neurons play a major role in the response to fasting and weight loss. To test this function, the researchers used a chemogenetic approach (engineering of protein receptors to respond to previously unrecognized small molecules) to either stimulate or inhibit specific neuronal populations. They injected an experimental model with an adeno-associated virus (AAV) coding for ...
- Source: drugdu
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Study provides a possible treatment option for prostate cancer resistant to hormone therapy

Prostate cancer is the most-commonly diagnosed malignancy and the second leading cause of cancer death among men in the United States. In its ever-indelicate world, the stubborn disease can continue to grow even when the amount of testosterone in the body is reduced to very low levels, thus earning the clumsy name: castrate-resistant prostate cancer (CRPC). It poses a major clinical challenge as a protein called the androgen receptor (AR) remains behind as a critical player in cancer, changing its behavior in CRPCs. Androgen-deprivation therapy, which is a treatment that reduces the levels of male hormones, is the first-line treatment for locally advanced or metastatic prostate cancer. Despite initial responses to the therapy, nearly all patients eventually develop CRPC within a few years. It is now well recognized that CRPC continues to be dependent on AR signaling. “Understanding the triggers that cause changes in AR’s activity is important for developing ...
- Source: drugdu
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Obesity impairs the brain’s response to nutrients, suggests study

Brain responses to specific nutrients are diminished in individuals with obesity and are not improved after weight loss, according to a study led by Amsterdam UMC and Yale University, published today in Nature Metabolism. “Our findings suggest that long-lasting brain adaptations occur in individuals with obesity, which could affect eating behavior. We found that those with obesity released less dopamine in an area of the brain important for the motivational aspect of food intake compared to people with a healthy bodyweight. Dopamine is involved in the rewarding feelings of food intake,” says Mireille Serlie, lead researcher and Professor of Endocrinology at Amsterdam UMC. “The subjects with obesity also showed reduced responsivity in brain activity upon infusion of nutrients into the stomach. Overall, these findings suggest that sensing of nutrients in the stomach and gut and/or of nutritional signals is reduced in obesity and this might have profound consequences for food ...
- Source: drugdu
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