Pharma News
28 Apr 2024 to 04 May 2024
May 3, 2024
US advises against Gilead's attempt to change ruling on HIV drug patents, according to Bloomberg Law.
The federal government has opposed Gilead Sciences Inc.'s request to modify a judgment regarding two drugs in its HIV-prevention regimen. The government argues that the request is untimely and improper, and that Gilead's concerns about potential misinterpretation do not warrant a change in the judgment. The case is currently in the US District Court for the District of Delaware.
May 2, 2024
Calquence, a promising cancer medication, successfully meets main goal in trial for initial treatment of mantle cell lymphoma.
AstraZeneca releases positive interim results for its BTK inhibitor, Calquence, in a Phase 3 trial for mantle cell lymphoma. The combination of Calquence with chemotherapy and immunotherapy showed increased progression-free survival compared to the use of chemotherapy and immunotherapy alone. The company deems the results statistically significant and clinically meaningful.
May 2, 2024
Novo Nordisk, the company behind Ozempic, issues a statement regarding the FTC's patent challenge - Quartz
Pharmaceutical company Novo Nordisk has responded to allegations from the U.S. Federal Trade Commission (FTC) that it filed "junk" patents for its drugs to hinder competition and increase prices. Novo Nordisk denies any wrongdoing, stating that the patents were approved by the patent office and followed FDA protocols. The FTC is disputing patent listings for Novo Nordisk's drugs, including Ozempic, Saxenda, and Victoza, specifically targeting device patents. The company has 30 days to withdraw or amend the listings or prove that they meet regulatory requirements.
May 2, 2024
Merck updates on advancements in cancer treatment while getting ready for the expiry of Keytruda's patent
Merck & Co Inc has reported encouraging data from its Phase III gastric cancer treatment trial. The trial evaluated the combination of Merck's immunotherapy drug, Keytruda, along with trastuzumab and chemotherapy for patients with gastric or gastroesophageal junction adenocarcinoma. The results showed a statistically significant and clinically meaningful improvement in overall survival. Merck also reported strong first quarter results, with sales of Keytruda and vaccine products driving revenue growth. The company is working on new deals and drug launches to offset the upcoming patent expiration of Keytruda.
May 2, 2024
Regeneron announces possible setback for Dupixent in COPD, and unchanging sales for Eylea
The approval of Sanofi and Regeneron Pharmaceuticals' Dupixent to treat chronic obstructive pulmonary disease (COPD) may be delayed due to additional efficacy analyses requested by the FDA. The regulator wants to see sub-population breakdowns from two trials before making a decision, which could result in a delay of up to three months. Despite this setback, Regeneron reported strong sales for its IL-4/13 inhibitor Dupixent and oncology treatment Libtayo. However, U.S. sales for the Eylea franchise were down 2% year-over-year.
May 2, 2024
Regeneron Reports Lower-Than-Expected Eylea Sales Impacting Q1 Earnings, According to BioSpace
Regeneron Pharmaceuticals missed Wall Street's expectations for earnings and revenue in the first quarter of 2024. The company's sales of its blockbuster eye drug, Eylea, dropped by 2%, primarily due to a reduced inventory and changing market dynamics. However, Regeneron's oncology portfolio, including its skin cancer drug Libtayo, saw significant growth. The company also announced a $3 billion share buyback program.
May 2, 2024
Novo Nordisk reduces cost of popular weight loss drug amidst increasing competition in the market.
Danish drugmaker Novo Nordisk has raised its 2024 outlook as it aims to boost output of its weight-loss treatment Wegovy. However, competition from rival Eli Lilly has forced Novo Nordisk to cut prices of the drug, leading to a drop in the company's shares. Novo Nordisk's first-quarter profits exceeded expectations, but Wegovy sales fell below market expectations. The company is gradually increasing the supply of lower-strength Wegovy doses in the US, but supply shortages persist. Despite these challenges, Novo Nordisk remains the most valuable company in Europe by market capitalization.
May 2, 2024
Novo Nordisk, a company that makes weight-loss drugs, reports a significant increase in profits according to Macau Business.
Danish pharmaceutical company Novo Nordisk has reported a 28% increase in net profit in the first quarter, reaching 25.4 billion kroner ($3.6 billion), due to the popularity of its anti-diabetes and weight-loss drugs Ozempic and Wegovy. Sales also rose by 24% to 65.3 billion kroner. Novo Nordisk has raised its outlook for 2024, expecting sales to increase by 19% to 27%. To meet the demand for its drugs, the company has acquired US drug manufacturing firm Catalent.
May 2, 2024
Sales of Wegovy increase significantly as Novo Nordisk benefits from the surge in popularity of weight loss drugs - Quartz
Danish pharmaceutical company Novo Nordisk has raised its full-year sales and operational profit guidance following booming sales of its diabetes and weight loss drugs Ozempic and Wegovy in Q1 2024. Sales of both drugs grew 25%, with Wegovy sales more than doubling year over year. Novo Nordisk has raised its sales outlook to between 19% and 27% and its operational profit to between 22% and 30%. The company is gradually increasing supply of Wegovy, which remains in shortage, and has already reached over 25,000 new weekly prescriptions.
May 2, 2024
Regulation of Morphine Reverted Following Unsuccessful Attempt to Prevent Shortages
The Drug Enforcement Administration (DEA) has reversed a regulation that was expected to cause shortages of morphine and other opioid injectables. The DEA had initially switched from annual to quarterly quotas in an attempt to prevent shortages but the change had resulted in the opposite effect. The DEA will now return to annual quotas.
May 2, 2024
Novo Nordisk sees increase in profits due to high demand for blockbuster obesity drug
Danish drugmaker Novo Nordisk has raised its 2024 outlook as it looks to increase production of its weight-loss treatment Wegovy. However, competition from rival Eli Lilly has forced Novo Nordisk to cut prices of the drug. Novo's shares fell after the announcement, but the company reported better-than-expected first-quarter profits. While Novo Nordisk has struggled to meet demand due to production constraints, Eli Lilly is expanding its manufacturing capacity for its obesity treatment Zepbound. The weight-loss treatment market is estimated to be worth up to $100bn by the end of the decade.
May 2, 2024
Boehringer Ingelheim Faces New Class Action Lawsuit Alleging Asthma Monopoly
A proposed class-action lawsuit alleges that pharmaceutical company Boehringer Ingelheim Pharmaceuticals holds an illegal monopoly on two drugs used in inhalation sprays to treat chronic obstructive pulmonary disease (COPD) and asthma. The lawsuit claims that Boehringer illegally prevented generic versions of the drugs, Combivent Respimat and Spiriva Respimat, from entering the market after the expiration of its patents on the active ingredients. The lawsuit seeks to represent all individuals and entities that indirectly purchased or paid for these drugs from February 23, 2020, onwards.
May 2, 2024
FTC goes against Big Pharma for unfair patents as Sanders supports regulatory action
The Federal Trade Commission (FTC) has launched a campaign against "junk" patents, targeting the pharmaceutical industry's pricing strategies. Supported by the Biden administration and Senator Bernie Sanders, the campaign challenges over 300 patents listed in the FDA's Orange Book, including Novo Nordisk's Ozempic. The FTC argues that these patents improperly prolong the monopoly periods of brand-name drugs, resulting in artificially high prices. The crackdown aims to facilitate easier market entry for generics, lower drug prices, and improve access to vital medications. Pharmaceutical companies defend their patent practices as essential for recouping high development costs.
May 2, 2024
Novo Nordisk, the company behind Ozempic, denies allegations of using excessive patents after facing criticism from the FTC
Pharmaceutical company Novo Nordisk has responded to the US Federal Trade Commission's (FTC) accusation that it filed "junk" patents to impede competition and raise prices. Novo Nordisk, the maker of diabetes drug Ozempic, denied any wrongdoing, asserting that the disputed patents were all approved by the patent office and followed FDA protocols. The FTC has disputed patents related to Novo Nordisk's Saxenda and Victoza brands, specifically targeting device patents. The FTC has given the drug manufacturers 30 days to withdraw or amend the disputed listings or prove compliance with regulatory requirements.
May 2, 2024
FTC Takes Action Against Invalid Patents on 20 Drugs, Including Ozempic - Obsev
The U.S. Federal Trade Commission (FTC) is challenging over 300 patents held by 10 drug companies, including popular weight loss drug Ozempic. The FTC sent warning letters to the companies, disputing the accuracy or relevance of the patents listed in the FDA's Orange Book. The disputed patents cover 20 different brand-name drug products, and the FTC claims that filing "bogus patent listings" blocks competition and raises the cost of prescription drugs. The FDA will give drug manufacturers 30 days to withdraw or amend challenged patent listings.
May 2, 2024
US disputes questionable patents on Ozempic and other medications to promote competition
The Federal Trade Commission (FTC) is challenging patents on 20 brand-name drugs, including the weight-loss injection Ozempic, in an effort to lower drug prices. The FTC sent warning letters to 10 drugmakers, alleging that certain patents filed by companies such as Novo Nordisk, GlaxoSmithKline, and AstraZeneca are inaccurate or misleading. The move is part of the Biden administration's strategy to address high drug prices and increase competition in the pharmaceutical industry.
May 2, 2024
Emergent BioSolutions Announces Strong Q1 Performance and Increases Outlook - TradingView
Emergent BioSolutions reported better-than-expected first-quarter earnings, with earnings per share of 59 cents, beating estimates by 171.08%, and sales of $300.4 million, exceeding estimates by 33.81%. The company also announced operational changes, including the closure of manufacturing facilities and a reduction in its workforce, to improve performance and profitability. These changes are expected to result in savings of around $80 million. Emergent raised its revenue guidance for 2024 to between $1 billion and $1.1 billion.
May 2, 2024
Emergent BioSolutions announces impressive Q1 performance and increases guidance for the future - Benzinga
Emergent BioSolutions (EBS) reported better-than-expected first-quarter earnings, with earnings per share of 59 cents and quarterly sales of $300.4 million. The company also announced operational changes, including the closure of manufacturing facilities and a reduction in its workforce by 300 employees. Emergent expects to save approximately $80 million from these changes and has raised its revenue guidance for 2024 to between $1 billion and $1.1 billion. EBS shares surged 70.9% following the news.
May 2, 2024
Trial begins in Cook County for the first lawsuit regarding cancer allegations linked to Zantac - ABC Chicago
The first trial over claims that the heartburn drug Zantac causes cancer has begun in Cook County. Angela Valadez is suing pharmaceutical companies GSK and Boehringer Ingelheim, alleging that the drug's active ingredient, ranitidine, turns into a cancer-causing substance called NDMA. This trial is the first test to determine if the claims will persuade a jury, as all previous cases have been dropped or settled. GSK and Boehringer Ingelheim maintain that there is no consistent evidence linking Zantac to cancer. The drug was recalled by the FDA in 2020 after NDMA was found in samples.
May 1, 2024
FTC focuses on Novo's Ozempic as one of over 300 patents labeled as 'junk' - Fierce Pharma
The U.S. Federal Trade Commission (FTC) is targeting over 300 patent listings by eight pharmaceutical companies in the FDA’s Orange Book, claiming that the patents are "junk" listings that could stifle competition and inflate drug prices. Companies like AstraZeneca, Boehringer Ingelheim, GSK, and Teva are under scrutiny, with Novo Nordisk's GLP-1 drugs Ozempic, Saxenda, and Victoza being the most high-profile products involved. The FTC argues that these improper patent listings exploit a policy that prevents the FDA from approving a generic drug for 30 months if there is a timely infringement lawsuit by the originator.
May 1, 2024
Upcoming Trial in Chicago to Address Zantac Cancer Allegations - USNews.com
The first trial over claims that heartburn drug Zantac causes cancer is set to begin this week in Chicago. The trial involves GlaxoSmithKline (GSK) and Boehringer Ingelheim as defendants, with other companies having settled already. The plaintiff alleges that she developed colorectal cancer as a result of taking Zantac from 1995 to 2014. This trial will be a test to see if the cancer claims can convince a jury, as previous cases have settled or been dropped. GSK and Boehringer Ingelheim maintain that Zantac does not cause cancer.
May 1, 2024
Eli Lilly increases its yearly profit outlook due to the success of its diabetes medication - Yahoo News Canada
Pharmaceutical company Eli Lilly has raised its annual revenue and profit forecasts after exceeding first-quarter sales expectations due to the demand for its diabetes drug Mounjaro. The drug may also be used to treat obesity, pending a decision from the US Food and Drug Administration. Data from a late-stage study showed that a high dose of the drug helped people with type 2 diabetes who were obese or overweight to lose nearly 16% of their body weight. Lilly expects regulatory action for the drug's use in obesity as early as late 2023.
May 1, 2024
United States disputes questionable patents on Ozempic and other medications to drive... - Dayton Daily News
The US Federal Trade Commission (FTC) has sent letters to several brand-name drugmakers, including Novo Nordisk, regarding questionable patent listings that may be blocking competition and inflating the cost of prescription drugs. The FTC is challenging the patents in an effort to bring down drug prices and increase access to more affordable alternatives. This move follows a similar action taken in September against over 100 patents held by various drugmakers.
May 1, 2024
Important updates on the government's actions against biotech that you should be aware of - STAT News
The Federal Trade Commission (FTC) has expanded its efforts to combat alleged patent abuses by the pharmaceutical industry. It has disputed over 300 patent listings across 20 drugs, including Novo Nordisk's Ozempic. Drug companies have been accused of filing improper or inaccurate patents to delay generic competition. The FTC's actions aim to prevent brand-name companies from extending their monopolies by listing more patents. This crackdown could have implications for the pharmaceutical industry and the availability of generic alternatives.
May 1, 2024
FTC focuses on challenging 'low-quality patents' related to Ozempic and other popular medications - BioPharma Dive
The Federal Trade Commission (FTC) has challenged over 300 patents filed with the US Food and Drug Administration (FDA) to protect market exclusivity for top-selling drugs, including Novo Nordisk’s Ozempic, Saxenda, and Victoza. The FTC alleges that the patents are either improper or inaccurate and could block cheaper, generic competition for expensive medications. The challenge comes as part of the FTC's efforts to fight against abuse of the FDA's Orange Book, which lists approved drugs along with patent listings.
May 1, 2024
FTC questions validity of patents for 20 popular drugs amid accusations of exaggeration by chairperson
The Federal Trade Commission (FTC) has raised concerns over the patents on 20 brand-name drugs, accusing drug companies of using "bogus" patents to inflate prices. The FTC argues that these patents prevent competition from generic drugs entering the market, resulting in higher costs for consumers.
May 1, 2024
FTC's Actions Against Questionable Patents Could Potentially Reduce Prices for Ozempic - Healthnews
The Federal Trade Commission (FTC) is targeting "junk" patents for weight loss medications, including Ozempic, which could lead to lower prices or the availability of cheaper generic versions. The FTC has sent warning letters to 10 pharmaceutical companies, including Novo Nordisk and AstraZeneca, urging them to amend the patent listings or certify compliance. The move aims to tackle the use of bogus patents that prevent competition and keep drug prices high. Analysis has shown that the manufacturing cost of medications like Ozempic is much lower than the retail price, indicating room for pricing adjustments.
May 1, 2024
FTC disputes patents for Ozempic in a bid to increase access to generic versions - Audacy
The Federal Trade Commission (FTC) has targeted "junk patents" held by pharmaceutical companies in order to increase the availability and affordability of weight loss medication. The FTC has sent letters to 10 different companies, including Novo Nordisk, AstraZeneca, and GlaxoSmithKline, challenging patents for drugs such as Ozempic, Saxenda, and Victoza. The FTC alleges that these patents were not properly listed. The move aims to tackle high drug prices and ensure timely access to affordable alternatives. However, legal challenges may arise as the companies could argue that the ingredients were falsely listed to delay generic versions.
May 1, 2024
FTC disputes 'fraudulent' patents related to Ozempic and other medications, as reported by MedPage Today
The Federal Trade Commission (FTC) has sent warning letters to 10 drugmakers challenging patents on 20 brand-name drugs, including semaglutide (Ozempic, Wegovy), a blockbuster weight-loss injection. The FTC alleges that certain patents filed by Novo Nordisk, GlaxoSmithKline, AstraZeneca, and seven other companies are inaccurate or misleading. The move is part of the Biden administration's efforts to target pharmaceutical industry practices that drive up drug prices. The drugmakers have 30 days to withdraw or update their patent listings or certify their legitimacy. This follows a similar action in September when regulators challenged over 100 patents held by drugmakers.
Apr 30, 2024
Upcoming trial on Zantac cancer allegations to commence in Chicago - TradingView
GSK and Boehringer Ingelheim are facing the first trial over claims that their heartburn drug Zantac causes cancer. The trial follows the settlement of other companies involved in the case. The plaintiff, an 89-year-old Illinois resident, alleges that she developed colorectal cancer as a result of taking Zantac and generic versions of it. The trial will test whether the cancer claims will convince a jury, as previous cases have settled or been dropped. The drugmakers maintain that Zantac does not cause cancer.
