PharmaFocus Today – Page 234 – media

Novo Nordisk says Wegovy can help heart disease patients—and not just because it produces weight loss

Novo Nordisk has made a splash with its GLP-1 drugs that have allowed patients to achieve significant weight loss. Now the Danish company appears on the verge of another breakthrough, showing that the use of its obesity treatment Wegovy can reduce the risk of heart attack in some patients. Perhaps even more importantly, Novo said this weekend in Philadelphia at the American Heart Association (AHA) Scientific Sessions that the cardiovascular benefits gained from Wegovy aren’t due solely to weight loss. The phase 3 SELECT trial showed that use of Wegovy versus placebo lowered the risk of a non-fatal heart attack by 28% and the risk of progression of chronic kidney disease and renal death by 22%. Additionally in the study—which included nondiabetic obese and overweight patients with established cardiovascular disease—Wegovy was found to reduce the risk of heart-related death by 15% and the risk of death by any cause by ...
- Source: drugdu
- 97
- November 15, 2023
Acon receives first FDA clearance for over-the-counter COVID-19 antigen test

Dive Brief The Food and Drug Administration has cleared the first over-the-counter COVID-19 antigen test via a traditional premarket review pathway. Acon Laboratories secured the 510(k) clearance for its Flowflex COVID-19 Antigen Home Test. The firm received emergency use authorization (EUA) in 2021 and, by following in the footsteps of Cue Health’s de novo molecular test, converted that approval into a conventional clearance. The clearance gives Americans another fully authorized test ahead of an infectious respiratory disease season in which testing volumes are forecast to be down compared to prior years. Dive Insight The EUA program enabled the FDA to quickly make COVID-19 tests available in the U.S. during the public health emergency. Today, the administration maintains EUAs on 65 antigen tests and 276 molecular diagnostic tests for COVID-19. While the EUAs remain in effect, the FDA is encouraging manufacturers to transition to its normal pathways now that the acute ...
- Source: drugdu
- 97
- November 14, 2023
New hope for TB patients as UNITE4TB launches clinical trial program

Today, UNITE4TB, an international public-private partnership striving to fast-track the development of innovative Tuberculosis (TB) treatments, announced the start of its phase 2B/C clinical trial program with the first participant enrolled at its trial site in Cape Town, South Africa. The announcement is a major milestone for the project and the TB community as a whole, helping to advance TB science and enhance the efficiency with which new treatments are delivered. The TB challenge TB is a major threat to public health, being among the leading causes of death worldwide. In 2021, the disease claimed the lives of 1.6 million people, making it the second leading infectious killer after COVID-19. Drug-resistant TB and long treatment regimens have increased the urgency for action and investment in TB research. For people affected by TB, the most important outcome is rapid access to better regimens of shorter treatment duration and with fewer side ...
- Source: drugdu
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- November 14, 2023
Optum Rx Moves Eight Preferred Insulin Products to Lowest Cost Tier

Eight rapid-, short-, and long-acting insulin products will move to tier one preferred status, which limits out-of-pocket spending to $35 or less for patients with diabetes. Optum Rx, the pharmacy benefit manager unit of UnitedHealth, announced that it is moving eight rapid-, short-, and long-acting insulin products to tier one preferred status, which offers the lowest cash price that consumers pay.1 The move, which goes into effect on January 1, 2024, will limit out-of-pocket spending to $35 or less for insulin product for patients with diabetes. Image credit: Aleksandra Gigowska | stock.adobe.com “I’ve seen firsthand how high prices for insulin and other necessary medications can cause patients to limit or skip doses,” said Patrick Conway, MD, MSc, chief executive officer of Optum Rx, in a press release.1 “Medicine that people can’t afford is useless, and by taking this important next step to change our formulary, we will lower costs and ...
- Source: drugdu
- 94
- November 14, 2023
Important Factors Differentiating Prescription Versus OTC Hearing Aids

It is important to understand that the performance of over-the-counter hearing aids can vary widely from prescription hearing aids due to a number of factors. By DR. CLIFF OLSON In October 2022, new Food and Drug Administration guidelines brought notable changes to the hearing aid market. The guidelines, which were mandated by the Over-the-Counter Hearing Aid Act of 2017, aim to improve hearing aid adoption rates by increasing the accessibility and affordability of hearing aid devices. Under the guidelines, direct-to-consumer (DTC) hearing devices that have been available for years will now be regulated by the federal government as over-the-counter (OTC) hearing aids. One of the specific measures implemented by the FDA guidelines was the establishment of “prescription hearing aids” and “over-the-counter hearing aids” as two distinct hearing aid categories. Given that OTC hearing aids can now be obtained without a hearing aid evaluation, they can be purchased at a lower cost from retail ...
- Source: drugdu
- 101
- November 14, 2023
Novo Pumps $6B into Manufacturing to Help Meet Sky-High Wegovy Demand

By Tristan Manalac Pictured: Novo Nordisk signage outside its office in California/iStock, Sundry Photography Novo Nordisk on Friday announced that it is investing more than $6 billion to boost manufacturing capacity in its home country of Denmark to meet current and future demand for products targeting serious chronic diseases. The Danish company will start rolling out the investment this year, with an initial $3.6 billion capital tranche and will continue to invest over the next six years. The additional funding will be channeled into facilities in Denmark, where the pharma giant currently has more than 23,000 employees—most of whom work at production sites. The multibillion-dollar manufacturing boost comes as Novo is struggling to keep up with the staggering demand for its weight-loss medication Wegovy (semaglutide). Manufacturing issues have also hounded the GLP-1 agonist, forcing the company to restrict the U.S. supply of the lower doses of the therapy. Novo will ...
- Source: drugdu
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- November 14, 2023
EU regulator changes its mind on Mirati’s KRAS inhibitor Krazati with a thumbs-up following initial snub

Mirati Therapeutics’ KRAS inhibitor Krazati’s EU prospects weren’t looking good after an initial rejection from Europe’s drugs regulator. Now, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has come around on the drug after taking a second look. The CHMP first rebuffed the med back in July, finding that it didn’t meet certain requirements for a conditional marketing authorization, despite acknowledging its positive risk-benefit profile. Mirati, disagreeing, filed for a formal re-examination that ultimately resulted in the recent positive opinion. Now, European patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC) will soon have a new treatment option in Mirati’s flagship drug. The company was already supplying the therapy to eligible patients in the EU based on “individual requests” from healthcare professionals, it said in July. This will be good news for Bristol Myers Squibb, which last month put $5.8 billion on the table ...
- Source: drugdu
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- November 14, 2023
Bristol Myers Squibb’s CAR-T Breyanzi wins FDA priority review

The US Food and Drug Administration (FDA) has granted priority review for Bristol Myers Squibb’s (BMS) Breyanzi (lisocabtagene maraleucel) to treat patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). The Prescription Drug User Fee Act (PDUFA) goal date for the therapy is now 14 March 2024. BMS submitted a supplemental biologics licence application (sBLA) to the FDA for the expanded use of Breyanzi for the treatment of patients with CLL and SLL who have previously received a Bruton tyrosine kinase inhibitor (BTKi) and a B-cell lymphoma 2 inhibitor (BCL2i). The application is based on results from the Phase I/II TRANSCEND CLL 004 study, which demonstrated clinical benefit with a CD19-directed CAR T cell therapy in patients with relapsed or refractory CLL after prior treatment with BTKi and BCL2i. In May 2023, BMS received approval from the European Commission (EC) for Breyanzi to treat relapsed ...
- Source: drugdu
- 95
- November 14, 2023
Takeda’s Fruzaqla receives FDA approval for metastatic colorectal cancer

Takeda’s Fruzaqla (fruquintinib) has been approved by the US Food and Drug Administration (FDA) for use in certain patients with previously-treated metastatic colorectal cancer (mCRC). Fruzaqla, which inhibits all three VEGF receptor kinases, has been specifically authorised for use in adults with mCRC who have been previously treated with chemotherapy, an anti-VEGF therapy, and in some cases, an anti-EGFR therapy. The FDA’s decision makes Fruzaqla the first targeted treatment options approved in the US for metastatic CRC regardless of biomarker status or prior therapies in more than a decade and was supported by results from the late-stage FRESCO and FRESCO-2 trials, which evaluated Fruzaqla plus best supportive care versus placebo plus best supportive care in previously-treated mCRC patients. Both trials met their primary and key secondary efficacy endpoints and showed consistent benefit among a total of 734 patients treated with Fruzaqla, Takeda said, adding that the drug demonstrated a “manageable ...
- Source: drugdu
- 95
- November 14, 2023
Valneva’s chikungunya vaccine approved by FDA for adults at increased exposure risk

Valneva’s chikungunya vaccine has been granted accelerated approval by the US Food and Drug Administration (FDA) for use in individuals ages 18 years and older who are at an increased risk of exposure to the mosquito-borne disease. The decision makes Ixchiq, which is administered as a single intramuscular injection, the world’s first licensed chikungunya vaccine. Chikungunya often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. Infection leads to symptomatic disease in up to 97% of people after three to seven days following the mosquito bite, with clinical symptoms including fever, joint and muscle pain, headache, nausea and rash. “Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. He added: ...
- Source: drugdu
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- November 14, 2023

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