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Study reveals elevated risk of ischemic stroke in women and men with migraine headaches

Reviewed by Lily Ramsey, LLM Women and men who experience migraine headaches also carry an elevated risk of having an ischemic stroke, but women alone may carry an additional risk of heart attack and hemorrhagic stroke, according to a new study led by Cecilia Hvitfeldt Fuglsang of Aarhus University, Denmark publishing June 13th in the open access journal PLOS Medicine. People diagnosed with migraine are believed to have a higher risk of experiencing a heart attack or stroke before the age of 60. Previous studies have suggested that the increased risk of ischemic stroke – when a blood clot blocks a blood vessel to the brain – mostly affects young women. It was unclear whether women with migraine also carry a higher risk of heart attack and hemorrhagic stroke – when an artery in the brain bursts – compared to men, which was the aim of the new research. Hvitfeldt ...
- Source: drugdu
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- June 15, 2023
Mark Cuban’s Cost Plus Drug Company projects huge savings over Medicare for generic cancer medications

By Neha Mathur Reviewed by Benedette Cuffari, M.Sc. In a recent article published in the Journal of Clinical Oncology, researchers reveal significant cost savings when generic oncology drugs are purchased through the Mark Cuban Cost Plus Drug Company (MCCPDC) as compared to Medicare. Study: Projected Savings for Generic Oncology Drugs Purchased via Mark Cuban Cost Plus Drug Company Versus in Medicare. Image Credit: Celil Kirnapci / Shutterstock.com Background There is an urgent need to reduce spending across the system in a dynamic healthcare landscape like that of the United States, which is possible with the equal participation of patients and sponsors. The Medicare program contributes a substantial proportion of prescription drug spending in the U.S., which was already high and continues to increase over time. In fact, in 2019, Medicare and its beneficiaries accounted for 27.2% of the fee-for-service program. Although oncology prescription drugs constituted only 0.6% of overall sales ...
- Source: drugdu
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- June 15, 2023
Valneva Reports Strong Phase III Chikungunya Vaccine Data After Merck’s Exit from Race

By Tristan Manalac Pictured: Syringe pulling vaccine from a vial / Adobe Stock, weyo Data from a Phase III study showed Valneva’s chikungunya vaccine candidate VLA1553 can elicit a strong immune response and could be an effective protective option against the mosquito-borne disease caused by the chikungunya virus, the French company announced Tuesday. This news follows a February 2023 report from Fierce Biotech revealing that Merck had dropped out of the chikungunya race. Citing a company spokesperson, Fierce noted that the decision to discontinue the chikungunya program was part of the company’s “routine pipeline prioritization.” Published Monday in the medical journal The Lancet, Valneva’s double-blinded and randomized Phase III study enrolled more than 4,100 participants who were given either VLA1553 or placebo. In the per-protocol analysis, the investigational shot induced neutralizing antibody titers above the protective threshold in 263 of 266 participants with evaluable findings. This corresponded to a 28-day ...
- Source: drugdu
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- June 15, 2023
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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- June 15, 2023
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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- June 15, 2023
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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- June 15, 2023
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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- June 15, 2023
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
- 106
- 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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- June 14, 2023

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