Meitheal Pharmaceuticals has signed an exclusive licensing agreement with the China-based Tonghua Dongbao Pharmaceutical to commercialise three insulin biosimilars in the US. The insulin biosimilars include two rapid-acting insulins, namely insulin lispro and insulin aspart, and the long-acting insulin glargine. The rights were acquired by Meitheal’s parent company Nanjing King-Friend Biochemical Pharmaceutical. Eli Lilly reported global sales of $440.4m for the branded version of insulin lispro Humalog in n Q2 2023, while Sanofi’s Lantus (insulin glargine) had global sales of $353m in the same period, as per the company’s Q2 financials. Meitheal will have exclusive US marketing rights after the insulin biosimilars are approved by the US Food and Drug Administration (FDA), which is expected in 2026. As part of the agreement, both Tonghua Dongbao and Nanjing King-Friend Biochemical would be responsible for the development and supply of all three insulin biosimilars. All three companies will also share the royalties ...
When it comes to heart failure medication, a labeling mix-up can have dire consequences. That’s why Marlex Pharmaceuticals of New Castle, Delaware, is recalling two lots of digoxin tablets at the 0.125-mg and 0.25-mg doses. The company is pulling the batches of the heart failure medication because certain bottles of 0.125-mg digoxin tablets are mislabeled with the 0.25-mg dose and vice versa. The labeling snafu could cause either overdosing of underdosing in patients who unknowingly take the wrong strength of medication, Marlex warned in a notice posted on the FDA’s website. Patients on 0.125-mg strength digoxin who take the higher dose could experience “significant drug toxicity” such as mental disorientation, dizziness, blurred vision, memory loss and fainting, the company added. Meanwhile, patients who take a subpotent dose may experience loss of control of heart rate and potential heart failure exacerbation, Marlex said. As of Thursday, Marlex said it hadn’t received ...
After months of legal wrangling, Amgen is free to go forward with its $27.8 billion buyout of Horizon Therapeutics. Friday, the U.S. Federal Trade Commission (FTC) said it reached a proposed consent order with Amgen to address the “potential competitive harm” that could result from the merger deal. Alongside the FTC, attorneys general from six states—California, Illinois, Minnesota, New York, Washington and Wisconsin—are moving to dismiss their injunction requests. The FTC first filed its antitrust lawsuit against Amgen in May in an attempt to block the sale. In its suit, FTC argued that Amgen could leverage its lucrative product portfolio to “entrench the monopoly positions” of Horizon’s thyroid eye disease drug Tepezza and the company’s gout treatment Krystexxa. For its part, Amgen has promised not to use that tactic with Horizon’s drugs. In a press release Friday, the company said it “has consistently stated to the FTC, the courts and ...
Zerva Therapeutics, formerly KemPharm, has announced a strategic acquisition of Acer Therapeutics to expand its rare therapies portfolio. The biggest Acer assets include the marketed rare therapy Olpruva (sodium phenylbutyrate formulation), and late-stage drug celiprolol. The acquisition is expected to be worth up to $91m in stock and cash payments, of which $76m is contingent upon milestone-based payments for Olpruva and celiprolol. Additionally, Zerva purchased Acer’s secured debt of more than $17m at a discounted value of $16.5m from its creditor, Nantahala Capital. The news caused Acer’s stock to skyrocket by 140% when the markets opened on 31 August. Zerva has a market cap of $165.25m, with a reported Q1 2023 revenue of $2.9m, as per the company’s financial report. Whilst Acer reported a loss of $8.1m in Q2 2023, as per the company’s Q2 financials. Olpruva is an oral suspension approved for the treatment of urea cycle disorders by ...
Pfizer’s respiratory syncytial virus (RSV) vaccine has been approved by the European Commission (EC) to protect both infants and older adults against RSV-caused lower respiratory tract disease (LRTD). The EC’s decision allows Abrysvo to be given as a single dose to adults aged 60 years and older, and those who are 24 to 36 weeks into their pregnancy to protect their babies from birth until they are six months old. RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people recover within a week or two, the virus can cause severe illness in young infants and older adults. In the EU, about 245,000 yearly hospital admissions have been associated with RSV in children aged under five years, while the virus is estimated to cause more than 270,000 hospitalisations in older adults each year. The EC’s decision, which follows a recent recommendation from the European Medicines ...
Amazon has announced that its online healthcare business, Amazon Pharmacy, will provide automated manufacturer-sponsored coupons for over 15 insulin and diabetes medicines to help patients access discounts pledged by the drug industry. The company said that patients will not need to search for and manually enter coupons using the new automatic coupon programme for three insulin makers: Novo Nordisk, Eli Lilly and Sanofi, lowering costs to as little as $35 a month. In March 2023, Novo, Lilly and Sanofi announced that they would be lowering their insulin prices by around 70% by or in 2024. A report published in July by Senator Elizabeth Warren said that some patients were struggling to get already discounted generic insulin from pharmacies at the guaranteed lower price. After Lilly lowered its Insulin Lispro list price in May to $25 per vial, patients were still being quoted up to $330 for the medicine and were ...
Nine states are saying not so fast to a proposed $13.5 million settlement that would get Eli Lilly out of hot water over claims it jacked up the price of its lucrative insulin product Humalog. The states argue Lilly is trying to use the deal to ward off future lawsuits by U.S. states. In a Tuesday filing in New Jersey federal court, lawyers for Arizona, Mississippi and Minnesota urged U.S. District Judge Brian Martinotti to delay approval of the deal unless it’s altered to make sure states can still file their own lawsuits over insulin prices. The states joined Illinois, Nebraska, Utah, Arkansas, Kansas and Montana in making their objections known this week. In a separate filing Monday, the group of six states argued that in light of local insulin price caps, Lilly was trying to settle claims valued at about $1 billion by offering price reductions that are already ...
In the aftermath of devastating wildfires on Maui, Bayer is standing up as one of the first pharmaceutical companies to offer relief. The German conglomerate is providing a cash donation of $250,000 to the island, plus a donation of essential healthcare products also worth $250,000. Bayer has operated in Maui for more than half a century, the company said in a Wednesday release. The company said it “stands in solidarity with those impacted and offers heartfelt condolences for the losses endured.” The fire in Lahaina, Hawaii, is now the deadliest in more than a century, according to the U.S. Fire Administration and CNN. To date, some 2,200 structures have been destroyed or damaged, 86% of which are residential, the state’s governor, Josh Green, has said. The death toll was 110 as of Wednesday. Of Bayer’s cash donation, $150,000 will go to the Hawaii Community Foundation’s Maui Strong program, which is ...
As companies have flocked to compete in the new respiratory syncytial virus (RSV) vaccine market, GSK has had the best timing. In May, the U.K. company was first to secure FDA approval for its shot Arexvy for adults 60 and older, beating out rivals from Pfizer and Moderna. And now—well in advance of the fall and winter RSV season—Arexvy is available in major U.S. retail pharmacies, GSK said Thursday. Under the Inflation Reduction Act, Medicare Part D patients will pay no out-of-pocket expenses for the shot, GSK said. Additionally, under the Affordable Care Act, patients with commercial insurance may be covered when Arexvy is administered in-network, GSK said. In June, the Advisory Committee on Immunization Practices (ACIP) recommended that people 60 and older decide in consultation with their healthcare provider whether to receive the RSV vaccine. As people age, their immune systems can become compromised, making them more vulnerable to ...
Speculation that Stada Arzneimittel may be looking for a buyout has largely been confirmed after the company’s CEO said as much in a recent German-language news story. Responding to recent acquisition rumors, Stada CEO Peter Goldschmidt told the German Press Agency, “Whether and when STADA might be sold is solely the decision of our owners; Bain Capital and Cinven.” From the company’s view, Goldschmidt said, “our owners are in an orientation phase in which initial exploratory talks are taking place.” A Stada press representative emailed a translated version of the remarks early Tuesday along with the company’s second-quarter results. Goldschmidt added that he doesn’t expect a decision before 2024. Additionally, the company’s investors “have no pressure to sell,” the CEO pointed out. “What speaks in favor of a sale process is that it is common for financial investors to exit after five to six years,” Goldschmidt opined. Early this month, ...
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