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SCOTUS hands win to Sanofi, Regeneron in long-running PCSK9 feud with Amgen

After numerous twists and turns, a highly divisive patent infringement case between Amgen and partners Sanofi and Regeneron has come to an end at the U.S. Supreme Court.The nine justices voted unanimously to uphold (PDF) a lower court ruling invalidating a pair of patents on Amgen’s PCSK9 cholesterol med Repatha. The case stretches back to 2014, when Amgen first sued Sanofi and Regeneron for allegedly treading on Amgen intellectual property with their rival PCSK9 drug Praluent, under development at the time as alirocumab. Praluent and Amgen’s Repatha won U.S. approvals just weeks apart in 2015. Both drugs work to help lower “bad” LDL cholesterol by blocking the protein PCSK9. In 2019, a judge ruled that certain claims of two Amgen patents covering Repatha were invalid. Amgen took that loss to federal appeals court, where it was rejected. The company ultimately petitioned the U.S. Supreme Court to hear the case in ...
- Source: drugdu
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- May 21, 2023
Cambrex wraps up expansion of Snapdragon API plant in Massachusetts

CDMO company Cambrex completed the second phase of an expansion at its Snapdragon Chemistry API production facility in Waltham, Massachusetts.The project added 51,000 square feet to the facility’s footprint, the company said in a May 16 press release. Among the new features at the plant are process R&D labs with 100-liter and 60-liter glass-lined steel reactors plus a 10-liter plug flow reactor, the company said. Cambrex didn’t reveal its total investment in the project. The company expects the new suites to be operating in June. “The capabilities and capacity added in Waltham are designed to support the industry’s most complex chemical development needs, consistent with Snapdragon’s expertise and history,” Tom Loewald, Cambrex chief executive, said in the release. Cambrex acquired Snapdragon for an undisclosed sum in November as part of its strategy to expand API offerings. With the deal, Cambrex picked up two Snapdragon facilities in Waltham. Prior to the ...
- Source: drugdu
- 133
- May 20, 2023
Abbott wins FDA spinal cord stimulation approval to challenge Nevro for back pain market

Dive Brief The U.S. Food and Drug Administration has approved Abbott’s spinal cord stimulation devices for the treatment of non-surgical back pain. Abbott landed the label expansion after showing its BurstDR spinal cord stimulation technology improved outcomes more than conventional medical management in people with chronic back pain who were ineligible for surgery. The label expansion comes 16 months after Nevro won FDA approval in non-surgical refractory back pain and four months after Boston Scientific released data on its rival device in the setting. Dive Insight: Abbott competes with Boston Scientific, Medtronic and Nevro for the spinal cord stimulation market and the four players are continually looking to expand into new areas where they are free from the intense competition that characterizes the core indications. Nevro unlocked an opportunity early last year, when it said it was the only company with specific labeling to treat non-surgical refractory back pain. Now, ...
- Source: drugdu
- 135
- May 20, 2023
US Appeals Court Panel Questions FDA Due Diligence on Abortion Pill

By Lisa Munger Pictured: Scales of justice/Kanizphoto, iStock A three-judge panel in Louisiana’s 5th Circuit Court of Appeals proffered probing questions during oral arguments Wednesday about whether the FDA had done due diligence before it made changes in recent years that made the abortion pill, mifepristone, more accessible. This comes after the U.S. Supreme Court granted the FDA’s application for a stay in April, effectively maintaining access to mifepristone as the case goes through the appeals process. Anti-abortion groups sued the FDA in November 2022, arguing that its approval of mifepristone in 2000 was flawed and subsequent changes to its usage lacked solid scientific evidence. The three-judge panel, consisting of Jennifer Walker Elrod, James C. Ho and Cory T. Wilson, raised questions about the FDA’s role in reviewing and approving medications during Wednesday’s hearing. “I don’t understand this theme [that] ‘the FDA can do no wrong.’ That is basically the narrative ...
- Source: drugdu
- 107
- May 20, 2023
FDA clears insertable cardiac monitor from Abbott

Abbott (NYSE:ABT) today announced that it received FDA clearance for its Assert-IQ insertable cardiac monitor (ICM). The Assert-IQ device offers a new option for diagnostic evaluation and long-term monitoring for irregular heartbeats. It supplements Abbott’s portfolio of connected health devices for managing and treating patients remotely. The device could potentially rival the Medtronic Linq system. A small device with sensors inserted just under the skin of the chest, Assert-IQ provides constant, real-time monitoring. It can detect and identify arrhythmias that lead to symptoms like fainting, irregular pulse and shortness of breath. Abbott says many commercially available ICMs monitor hearts for “a few years,” but Assert-IQ offers two options. With a battery life of at least three or six years, it can provide doctors with a new level of flexibility in diagnostic monitoring. The three-year option offers a method for more traditional monitoring. That includes diagnosing fainting, heart palpitations or abnormal ...
- Source: drugdu
- 117
- May 20, 2023
Pfizer puts kibosh on 4 antibiotics in India after contractor’s manufacturing issues

Global drug giant Pfizer is warning physicians and clinicians in India to immediately stop using four of its antibiotics due to manufacturing issues at a contract producer.The warning covers Magnex, Zosyn, Magnamycin and Magnex Forte. All four products treat infections, with Zosyn used to target various infections caused by bacteria including stomach infections, skin infections, pneumonia, and severe uterine infections. Magnamycin injections and Magnex Forte are also used to treat bacterial infections. The company issued the warning because of “deviations” at a manufacturing facility operated by Astral Steritech Private Limited, according to a letter shared on Twitter by Dr. Sudhir Kumar, M.D., of Apollo Hospitals in Hyderabad. “Whilst the manufacturer is currently investigating the matter, they have requested Pfizer, as an abundant precautionary measure and as per best practices, to temporarily suspend the sale/distribution/supply and use of the aforementioned products, pending the investigation by the manufacturer,” the company said in ...
- Source: drugdu
- 115
- May 20, 2023
CDC urges mpox vaccination among people at high risk to prevent summer surge

The Centers for Disease Control and Prevention on Thursday urged gay men and other individuals at high risk from mpox to get fully vaccinated to prevent a summer resurgence of the virus. The CDC’s call for those at risk to get up to date on their vaccines comes after a cluster of at least 21 mpox cases was reported in the Chicago area this month. Many of the people who caught mpox in the Chicago cluster were partially or fully vaccinated against the virus, raising questions about whether immunity from the shots might wane over time. The patients in the Chicago cluster all have mild symptoms, said Demetre Daskalakis, deputy head of the White House mpox task force, on a call with reporters Thursday. Daskalakis said no vaccine is perfect but people who have received two doses have a much lower risk of catching and spreading the disease. Vaccination also ...
- Source: drugdu
- 104
- May 20, 2023
FDA advisors recommend Pfizer’s RSV vaccine for infants but raise safety concerns

The U.S. Food and Drug Administration’s independent panel of advisors Thursday recommended full approval of Pfizer’s vaccine that protects infants from respiratory syncytial virus, but raised safety concerns over premature births that may be tied to the shot. The committee unanimously said the vaccine efficacy data was sufficient. Ten of the advisors said the safety data on Pfizer’s shot was adequate, while four said it was not. “If the vaccine actually lives up to the data we’ve seen today, I can guarantee many infants and their parents will breathe easier in the coming years,” said Dr. Jay Portnoy, medical director at the Children’s Mercy Hospital in Kansas City, after voting in favor of the safety and efficacy of the shot. Dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia, said he doesn’t believe there is enough data that indicates the safety of the vaccine is “reassuring.” “If ...
- Source: drugdu
- 113
- May 20, 2023
Melanin structure discovery brings scientists one step closer to developing ultra-protective sunscreen

A new discovery about the structure of melanin has brought scientists one step closer to developing a new, potentially ultra-protective sunscreen derived from a biological substance found in nearly all organisms. Researchers from McGill’s Department of Chemistry, in collaboration with The Ohio State University and the University of Girona, have announced a major advance in understanding the fundamental structure of melanin and one of its components that turns light into heat, protecting the body from sun damage. Melanin, the pigment that gives humans their skin, eye, and hair colour, is the body’s first and best natural defense against the sun’s harmful rays. Cosmetics companies have long tried to harness the protective powers of natural and synthetic melanin for use in chemical sunscreens and other personal care products. For example, melanin could, in theory, be used to produce a radiation barrier that augments skin care products by matching a more diverse ...
- Source: drugdu
- 125
- May 20, 2023
Despite Economic Pressures, 90% of Employers Will Continue Wellbeing Programs, Survey Shows

Although employers are facing a difficult economic climate, nine in 10 said it will not lead to them reducing their investment in wellbeing programs for their employees, according to a new survey. Another three in 10 employers plan to increase their investment into wellbeing programs. The survey was published Wednesday by Fidelity Investments and Business Group on Health. It was conducted between December 2022 and January 2023 and received responses from 184 employers. Most of the employers have a global presence. Despite employers looking to maintain their wellbeing investments in the next three to five years, some areas of wellbeing will be emphasized more than others, the survey found. About 74% of respondents said they will expand mental health, 53% said they will expand financial wellness, 52% said they will expand work/life balance and 50% said they will expand physical health. Mental health, physical health and financial health are all ...
- Source: drugdu
- 116
- May 20, 2023

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