STAT

OCTOBER 18, 2023

Investors in biopharma companies, who lobbied vigorously — but unsuccessfully — against allowing Medicare to negotiate drug prices, are trying a new tactic to preserve their profits. The fight over drug prices is far from over.

Drug Pricing 273

Drug Pricing 273

STAT

DECEMBER 11, 2023

Arduini has been GE HealthCare’s CEO since January 2022; before that, he was the CEO of neurosurgery device company Integra LifeSciences. “The timing of Peter Arduini’s election as our new Chair couldn’t be better,” AdvaMed CEO Scott Whitaker said in a press statement.

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STAT

DECEMBER 4, 2023

It was supposed to help Novak, then the chief executive of CRISPR Therapeutics, navigate a pressing quandary. His company was founded to commercialize the new revolutionary gene-editing tool CRISPR-Cas9, which promised to cure numerous genetic diseases. But which should they target first?

Hospitals 274

Hospitals 274

STAT

JANUARY 4, 2024

Contraline, a device startup that released early, positive clinical data in a press release on Thursday, hopes to fill it. The company has built an injectable gel that’s inserted into the sperm duct, physically blocking the sperm from coming out.

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STAT

JULY 11, 2023

The company said in a press release that it will review whether to proceed with trying to bring the vaccine to the U.S. Takeda announced Tuesday that it has voluntarily withdrawn its application to the Food and Drug Administration for its dengue vaccine, making it unclear when or if the vaccine will be licensed in this country.

Vaccines 246

Vaccines 246

STAT

OCTOBER 4, 2022

The press release issued by pharmaceutical companies Eisai and Biogen on Sept. 27 might someday be remembered as the beginning of a revolution in Alzheimer’s diagnosis and treatment.

Pharmaceutical Companies 308

Pharmaceutical Companies Pharmaceutical Companies Drug Development 308

STAT

APRIL 10, 2023

Neither company issued a press release. UnitedHealth Group has acquired Crystal Run Healthcare, a prominent physician group in New York. The deal for Crystal Run, a network of almost 400 doctors, nurse practitioners, and other clinicians, closed in late February. There was no fanfare. Continue to STAT+ to read the full story…

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STAT

JANUARY 5, 2023

More than a year after Al Sandrock was pushed out as Biogen’s R&D chief, the company has set permanent plans to replace him into motion. The company has initiated a search for a new research chief, it said in a press release. Both positions will report directly to new CEO Chris Viehbacher.

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STAT

MARCH 28, 2023

Viking Therapeutics, a small biotechnology company, said Tuesday that its experimental medicine led patients to lose as much as 6% more body weight than those on placebo in just six days. Continue to STAT+ to read the full story…

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STAT

AUGUST 9, 2023

Minutes after the company issued its press release, shares in Illumina dipped from $184.49 to below $172 during after-hours trading.

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STAT

FEBRUARY 14, 2023

WASHINGTON — A popular Chinese vape company says it is donating thousands of dollars to the American Cancer Society in an effort to stop youth vaping, but the cancer organization says it never agreed to the partnership, and it’s ordering the company to stop. ” Read the rest…

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STAT

JANUARY 24, 2023

The massively funded research and development company is without a chief scientific officer after the celebrated biologist David Botstein quietly retired last year. A spokesperson for the press-shy company confirmed Botstein’s exit in an email, but would not elaborate on plans for a replacement.

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BioPharma Dive

FEBRUARY 15, 2024

Analysts pressed Alnylam executives on the reasons for the changes to HELIOS-B, a Phase 3 study in ATTR amyloidosis with cardiomyopathy that is important to the company’s future.

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STAT

APRIL 6, 2023

They’ve swiftly caught the attention of subway goers: splashy ads plastered on train station walls and turnstiles across New York by telehealth companies promoting controversial weight loss medications like Wegovy by name.

Labelling 255

Labelling Diabetes 255

STAT

JULY 13, 2023

Vessey will become an executive partner and chief scientist at Flagship starting July 31, according to a press release. He will work with the teams at Flagship that create new startups, helping them with science and R&D strategies. It’s the first time the firm will have a chief scientist.

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STAT

MAY 11, 2023

Reynolds is suing the state of California in an effort to keep a controversial new line of cigarettes on shelves, the company announced Thursday in a press release. WASHINGTON – Tobacco giant R.J. Reynolds launched the products in question shortly after California voters endorsed a statewide ban on menthol cigarettes.

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STAT

JULY 13, 2023

In a clinical trial dubbed OCARINA II , the company showed that delivering Ocrevus, a treatment for certain forms of multiple sclerosis, as a 10-minute injection beneath the skin worked just as well as the current standard, an intravenous infusion that takes hours to deliver.

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STAT

AUGUST 8, 2023

The company reported only the top-line figure in a press release Tuesday, and did not break out the reductions it said were seen in heart attacks, strokes, and cardiovascular deaths — the combined components of the study’s primary outcome.

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pharmaphorum

MARCH 1, 2024

There is a pressing need for companies to transition their EU clinical trials that are ongoing under the “old” regulatory framework of the Clinical Trials Directive to the Clinical Trials Regulation. The risk for those that don’t meet the 30th January 2025 deadline for transition is that they will lose their legal basis.

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STAT

JUNE 21, 2023

BRUSSELS — Leaders of European pharmaceutical companies on Wednesday said that a proposed overhaul of the E.U.’s But the proposed legislation from the European Commission “would do the opposite,” Jørgensen added, because it would lead to fewer medications for patients.

Pharmaceutical Companies 246

Pharmaceutical Companies Pharmaceutical Companies 246

STAT

SEPTEMBER 5, 2023

Health care leaders and technology companies are investing heavily in large language models, a powerful class of deep learning models that are trained on vast troves of data. But while enthusiasm for generative AI is high and research is booming, it’s just starting to gain a toehold in clinical settings.

Hospitals 353

Hospitals 353

STAT

MAY 17, 2023

In the 156-volunteer trial, the drug, sepiapterin, reduced levels of phenylalanine by 63% compared to a placebo, PTC said in a press release. The company did not release detailed results, but said that no severe adverse events occurred in the study.

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STAT

JULY 26, 2023

Palette will bring Teleflex an extra $56 million in sales, the company estimated in a press release. The company offers just one urological treatment: the UroLift system to relieve an enlarged prostate. Teleflex develops a range of devices, but makes the most money from vascular products like catheters.

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STAT

OCTOBER 18, 2023

… Investors in biopharma companies, who lobbied vigorously — but unsuccessfully — against allowing Medicare to negotiate drug prices, are trying a new tactic to preserve their profits , The Boston Globe tells us. 

Drug Pricing 265

Drug Pricing 265

STAT

MARCH 4, 2024

The judge decided AstraZeneca had not proved the program jeopardizes its constitutional property rights, and that the company did not have standing to challenge the guidance Medicare issued to implement the program. … A U.S.  The decisions come more than a year after the U.S.

Drug Pricing 264

Drug Pricing Labelling 264

STAT

NOVEMBER 29, 2022

Using Google’s AI Model — and its cloud infrastructure, which I’ll share more about later — could boost adoption of iCAD’s broader cancer detection services, an executive said in a press release. Read the rest…

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STAT

FEBRUARY 2, 2024

As media reports have highlighted, the new effort — a press release says that it was “ inspired by the success of Bell Labs” — promises to let scientists engage in research without first getting funding from NIH or other sources, as well as the option, if the results are promising, to spin off a for-profit company.

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The Guardian - Pharmaceutical Industry

APRIL 5, 2024

Testing of 40 types of bandages made by companies such as Band-Aid, Curad, Walmart and CVS found 26 products, or 65%, contain alarming levels of a marker of PFAS. The chemicals were detected in the adhesive flaps and in absorbent pads that press against wounds. Continue reading.

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FDA Law Blog: Biosimilars

FEBRUARY 7, 2024

Gilbert — Last week, DEA and DOJ announced a $59 million civil penalty settlement with eBay related to the failure to comply with Controlled Substances Act (CSA) requirements for identifying purchasers, maintaining records, and filing reports of individuals selling/purchasing pill presses and encapsulating machines.

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Controlled Substances Documentation 116

Express Pharma

MAY 2, 2024

A press statement from Bayer informed, “The JV successfully leveraged the strengths of both companies to better serve the fast-growing Indian market. The 50:50 joint venture was established on January 28, 2011, for the sales and marketing of pharmaceutical products in India.

Diabetes 102

Diabetes 102

STAT

OCTOBER 3, 2022

During talks in 2020 and 2021, the company turned down a request to hand over the recipe for its vaccine due to commercial and safety concerns, although Moderna is still “eager” to sell the product to China. Moderna was pressed to take the former option. Continue to STAT+ to read the full story…

Drug Pricing 246

Drug Pricing Vaccines 246

STAT

MAY 5, 2023

 The price update comes more than a month after lawmakers on the Senate HELP Committee pressed Moderna chief executive officer Stephane Bancel to justify a $130 price point given the $12 billion the government spent to speed the company’s clinical trials and purchase its vaccine.

Vaccines 246

Vaccines 246

STAT

AUGUST 8, 2023

The company reported only the topline figure in a press release and did not break out the reductions in heart attacks, strokes, or cardiovascular deaths. billion in 2020 to acquire another company called Dermira, which was developing a competing medication to treat atopic dermatitis.

Drug Development 246

Drug Development 246

STAT

JULY 5, 2023

 The company bought more than 457,000 meals to educate doctors and other prescribers about its portfolio of drugs known as GLP-1 agonists, according to data from the Centers for Medicare and Medicaid Services. Nearly 12,000 prescribers had food paid for by the company more than a dozen times last year.

Diabetes 244

Diabetes 244

STAT

JANUARY 10, 2023

Food and Drug Administration is pressing pause on drug-company testing of experimental medicines more often, a side effect of the industry’s move into promising but less-proven technologies , The Wall Street Journal reports. And please do reach out if you hear something saucy or head spinning. … The U.S.

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MARCH 30, 2023

Food and Drug Administration approved selling Narcan — the brand name for naloxone — without a prescription, setting the overdose-reversing drug on course to become the first opioid treatment drug to be sold over the counter, the Associated Press writes.

Vaccines 246

Vaccines 246

BioPharma Dive

FEBRUARY 7, 2024

Analysts pressed company executives Tuesday on the potential of its GLP-1 drug for weight loss, early-stage results for which were published this week.

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