Search Results for “Sanofi” – Page 14 – media

In cutting sales guidance, EuroAPI cites CDMO industry struggles and customers’ inventory reductions

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 ...
- Source: drugdu
- 109
- October 11, 2023
What Pharma Fears Most About AI

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 ...
- Source: drugdu
- 124
- October 6, 2023
Roche scores—again—in hemophilia drug patent case against Takeda

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. ...
- Source: drugdu
- 187
- October 1, 2023
Meitheal partners with Chinese company for US licencing of insulin biosimilars

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 ...
- Source: drugdu
- 96
- September 30, 2023
Delaware’s Marlex Pharmaceuticals recalls 2 batches of heart failure drug after labeling mix-up

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 ...
- Source: drugdu
- 221
- September 6, 2023
Amgen’s $28B Horizon buyout cleared for takeoff after FTC, states settle

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 ...
- Source: drugdu
- 108
- September 5, 2023
Zerva acquires Acer Therapeutics to bolster rare disease portfolio

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 ...
- Source: drugdu
- 103
- September 4, 2023
Pfizer’s RSV vaccine granted EC approval to protect infants and older adults

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 ...
- Source: drugdu
- 125
- August 30, 2023
Amazon Pharmacy to provide automated discounts for insulin in the US

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 ...
- Source: drugdu
- 122
- August 20, 2023
Lilly’s $13.5M insulin pricing settlement gets pushback from 9 states

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 ...
- Source: drugdu
- 142
- August 20, 2023

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