Author: IQ TIMES MEDIA
By Sneha S K Feb 10 (Reuters) – The U.S. Food and Drug Administration will not review Moderna’s (MRNA) approval application for its influenza vaccine, the company said on Tuesday, sending its shares down 8% in extended trading. In its refusal-to-file letter, the FDA said Moderna’s choice to compare mRNA-1010 to an already licensed standard-dose seasonal influenza was the sole reason for the refusal to initiate a review of the application. The letter specifically cited the lack of an “adequate and well-controlled” study with a comparator arm that “does not reflect the best-available standard of care,” Moderna said. “This decision…
SHANGHAI, Feb 11 (Reuters) – Eli Lilly has won Chinese regulators’ approval for its drug to treat chronic inflammatory bowel disease, expanding the treatment’s use to the world’s second-largest pharmaceutical market, it said on Wednesday. The drug, mirikizumab, is authorised as a treatment for moderately-to-severely active Crohn’s disease and ulcerative colitis, the U.S. drugmaker said in a statement on its official WeChat account. The decision marks its China branch’s first approval for an innovative medicine in the digestive immunity field, according to the statement. The drug is already approved for treatment in several other countries, including the U.S. Lilly, which…
By Rashika Singh Feb 11 (Reuters) – Shares of Moderna slumped nearly 9% in premarket trading on Wednesday after the U.S. Food and Drug Administration declined to review the company’s application for approval of its experimental influenza vaccine, underscoring shifts in U.S. vaccine policy. The decision deals a blow to Moderna’s ambitions to plug the decline in its COVID-19 vaccine revenue and demonstrate the long-term viability of its mRNA platform. Sweeping changes to U.S. vaccine policy under Health Secretary Robert F. Kennedy Jr., a longtime antivaccine activist, have led to reduced vaccine usage and sparked concerns about public health risks…
By Emma Rumney LONDON, Feb 12 (Reuters) – A potential U.S. move to block imports of some disposable vapes could cut the booming market for unregulated e-cigarettes by as much as a third, British American Tobacco’s CEO told Reuters on Thursday, though any impact is unlikely before 2027. Tobacco giants including BAT and U.S. Marlboro-maker Altria have spent years fighting a flood of mostly Chinese-made vapes that lack U.S. authorisation for sale but have still come to dominate the world’s largest market for smoking alternatives. BAT estimates unregulated devices make up about 70% of U.S. e-cigarette sales, hitting both its…
Feb 12 (Reuters) – Eli Lilly had $1.5 billion worth of pre-launch inventory of its experimental oral weight-loss drug, a filing showed on Thursday, ahead of an expected decision by the U.S. Food and Drug Administration in April. Last year, the company had said it had nearly $550 million in pre-launch inventory for the pill, orforglipron. Lilly has previously said it would have plenty of supply to launch the much-anticipated weight-loss pill in several countries nearly simultaneously if the pill wins U.S. approval. Danish rival Novo Nordisk launched its once-daily weight-loss pill in the U.S. earlier this month, with prescriptions…
PARIS, Feb 13 (Reuters) – French chemical company Eurolysine has filed a complaint with the European Union saying that a reduction in prices of Chinese lysine, used in animal feed, has made penalties to stop unfair pricing ineffective, it said on Friday. The move highlights wider concerns over cheap Chinese imports affecting several sectors and stoking trade spats between the world’s second-largest economy and the 27-member bloc. Eurolysine, the EU’s sole fermentation-based amino acid producer, said market conditions for lysine, valine and tryptophan had worsened for more than six months, arguing that Chinese prices have fallen below production costs. Lysine,…
By Diana Novak Jones Feb 13 (Reuters) – A jury in Pennsylvania state court on Friday awarded $250,000 to the family of a woman who sued Johnson & Johnson (JNJ) alleging its talc-based baby powder was to blame for her ovarian cancer, according to an attorney for plaintiffs in nationwide talc litigation against the company. The jury in the Philadelphia Court of Common Pleas sided with family members of Gayle Emerson, who claimed that Johnson & Johnson knew for years its talc-based products were dangerous but failed to warn consumers, according to attorney Chris Tisi. Jurors awarded Emerson’s family $50,000…
Feb 17 (Reuters) – Medtronic surpassed Wall Street expectations for third-quarter profit on Tuesday, buoyed by strong demand for its heart devices and diabetes monitors. Medtech firms are benefiting from surging demand for medical procedures as health insurers report higher medical loss ratios — an indication that patients are availing more procedures. Market optimism is also boosted by wider physician uptake and technological advances. The company maintained its fiscal 2026 adjusted per share profit forecast at $5.62 to $5.66. Medtronic’s growth drivers include its pulsed field ablation systems and its transcatheter aortic valve replacement devices, two minimally invasive technologies seeing…
Bayer said on Tuesday that its Monsanto chemical subsidiary has proposed a $7.25 billion settlement to resolve lawsuits by customers alleging that its Roundup weedkiller product caused non-Hodgkin lymphoma. If the settlement wins court approval, Monsanto would make annual payments for up to 21 years. People diagnosed with non-Hodgkins lymphoma who were exposed to Roundup before the proposed legal remedy was announced on Tuesday can file a claim to receive payments, according to Reuters. Non-Hodgkins lymphoma is a type of cancer that develops in white blood cells called lymphocytes, which are part of the body’s infection-fighting immune system. Bayer said…
Feb 17 (Reuters) – Tylenol-maker Kenvue on Tuesday beat Wall Street estimates for fourth-quarter results and announced a global workforce reduction, as it proceeds toward a planned takeover by Kimberly-Clark. Kenvue said its board has approved a plan to optimize its operating model, resulting in a net reduction of its global workforce by about 3.5%. The company had about 22,000 employees as of last year. Kleenex-maker Kimberly-Clark in early November proposed buying Kenvue for more than $40 billion to create a global consumer health company with brands like Band-Aid and Huggies diapers. The merger is expected to close in the…