By Kate Goodwin Bayer is looking to shake things up with some major company changes after reporting “not acceptable” cash flow for the third quarter on Wednesday. “We’re not happy with this year’s performance,” CEO Bill Anderson said in a statement accompanying third-quarter results that were down against the previous year, while emphasizing a need for redesigning the company to focus only on what’s essential for its mission of “health for all, hunger for none.” As part of a significant, unspecified reduction in its workforce, Bayer will remove “several layers” of management, according to Wednesday’s announcement. The goal is to shift the majority of decision-making from the managers to the people doing the work, Anderson said, adding that 12 layers of management between him and the company’s customers were “simply too much.” The company reported nearly 50 billion euros, or $53.3 billion, in revenue with what Anderson called “zero cash ...
A new research institute in London has been launched aimed at discovering a cure and new treatments for motor neurone disease (MND). The UK Motor Neuron Disease Research Institute (UK MND RI) will bring together a virtual network of MND labs, clinical centres and researchers to carry out MND research across the UK. Affecting one in every 300 people in the UK, MND is a neurodegenerative disease which affects the nerve cells in the brain and spinal cord. Around one-third of patients with MND die within one year of diagnosis, and more than half within two years. Currently, Sanofi’s Rilutek (riluzole) is the only licenced drug for MND in the UK. Collaboratively, doctors, clinicians, scientists and people living with MND, along with funders and charities, will work to speed up drug discovery and drug development and aim to test potential treatments in clinical trials. LifeArc, the MND Association, MND Scotland, ...
As COVID revenues dwindle for pandemic stalwart Pfizer, the company is turning attention to its respiratory syncytial virus (RSV) vaccine launch and a potential entry into the hot obesity market. With only five months of sales under its belt, Pfizer’s RSV vaccine Abrysvo is “doing better than we thought,” Chief Commercial Officer Angela Hwang said on the company’s third-quarter earnings call, touting “very fast uptake” for the new shot. After a pair of approvals in late May and August, Abrysvo pulled in revenues of $375 million during the third quarter, Pfizer said Tuesday. Earlier this year, the shot won FDA nods to immunize older adults and then as a maternal vaccination to protect infants. In both settings, the Pfizer offering is facing off against Big Pharma competition. In the adult RSV vaccine marketplace, Pfizer is challenging GSK and its immunization Arexvy. GSK is set to report its third-quarter results Wednesday. ...
By Kate Goodwin Pictured: Eli Lilly world headquarters/iStock, jetcityimage A 52-week study finds Eli Lilly’s mirikizumab to be effective for long-term remission in over half of patients with Crohn’s disease. The company announced Thursday plans to submit a marketing application to the FDA for approval in 2024, followed by submissions to other global regulatory agencies. In the Phase III trial, moderately to severely active Crohn’s disease patients on mirikizumab demonstrated clinical remission as well as endoscopic response at the one-year mark. Over 54% of the patients in the treatment arm achieved clinical remission at week 52, versus 19.6% of those receiving placebo. The endoscopic response was seen in 38% of those on mirikizumab versus 9% on placebo. Safety was consistent with the known profile of the therapy with the frequency of serious adverse events greater in the placebo arm than the treated group, according to Lilly. The interleukin-23p19 antagonist demonstrated ...
Flush with business during the COVID pandemic, the CDMO industry is struggling to adjust in the aftermath. Case in point is EuroAPI, which has slashed its projected revenue growth in 2023 from a range of 7% to 8% to a new window of 3% to 5%. The Sanofi drug ingredients spinoff also has dropped its estimated earnings growth from between 12.5% and 13.5% to range of 9% to 11%. During a conference call on Monday, CEO Karl Rotthier chalked the changes up to pricing pressures resulting from lower inflation, coupled with “inventory reduction programs implemented by some of our customers.” Rotthier also mentioned the “biotech funding crisis.” He said that more than 20 of the company’s projects have been delayed, reduced in scope or halted altogether. The board of EuroAPI has begun to conduct a strategic review of its operating model. The company’s midterm view of its prospects from 2023 ...
As artificial intelligence (AI) hovers between a “buzz phrase” and marveled reality, many point to the potential the technology has in the pharma industry. While some criticize the rate at which pharma uptakes new technologies and implements them into their processes, the industry must also strike a fine balance with moving cautiously when it comes to changes due to the nature of the industry and the potential impact on patients those changes can bring. But it can’t be denied that there is a plethora of data in every part of the process of drug creation and distribution that needs to be more efficiently managed and utilized—from preclinical and R&D to manufacturing to commercialization and distribution. But perhaps one of the greatest appeals of AI is the potential it has for innovation. Andrew Hopkins, founder and CEO of Exscientia, an AI-driven precision medicine company founded in 2012, shares in this Q&A ...
In a patent case centered on two rival hemophilia medicines, Roche’s Genentech unit has scored its second straight win. After a U.S. district court last year ruled in favor of Roche and invalidated a patent held by Takeda’s Baxalta unit, the U.S. Court of Appeals for the Federal Circuit reaffirmed the ruling. In the decision, U.S. Circuit Judge Timothy B. Dyk wrote that in order to be valid, patents must describe inventions “in such full, clear, concise and exact terms” so that any skilled person can make and use the same product “without undue experimentation.” In this case, Baxalta’s patent describes an antibody that binds to a protein that’s key to enable blood clotting. In its appeal, Baxalta argued that skilled practitioners can use a screening process that doesn’t amount to undue experimentation. But the circuit court shot down this argument, supporting the decision that the patent should be invalidated. ...
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 ...
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