Sat.Apr 20, 2024 - Fri.Apr 26, 2024

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H5N1 bird flu virus particles found in pasteurized milk but FDA says commercial milk supply appears safe

STAT

WASHINGTON — Testing conducted by the Food and Drug Administration on pasteurized commercially purchased milk has found genetic evidence of the H5N1 bird flu virus, the agency confirmed Tuesday. But the testing, done by polymerase chain reaction, or PCR, cannot distinguish between live virus or fragments of viruses that could have been killed by the pasteurization process.

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Vistagen’s on-demand nasal spray could provide a novel option for social anxiety

PharmaVoice

The fast-acting medication is one of a few new approaches being tested for the crippling condition.

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Top 20 global biopharma companies report 9.6 per cent market cap growth in Q1 2024: GlobalData

Express Pharma

Despite the ongoing uncertainties surrounding macroeconomic activities, fluctuating interest rates, and changes in the Medicare Drug Price Negotiation landscape, the top 20 global biopharma companies experienced a promising first quarter this year. They reported a total increase of 9.6 per cent in market capitalisation from $3.67 trillion as on 31 December 2023 to $4 trillion as on 31 March 2024, reveals GlobalData.

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What pharma stands to gain from technological innovation

pharmaphorum

Pharmaceutical companies stand to gain significant benefits from technological innovation in the form of improved data analytics, streamlined healthcare processes, and enhanced patient outcomes. Explore the potential advantages for the pharma industry.

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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USDA releases H5N1 bird flu genetic data eagerly awaited by scientists

STAT

The U.S. Department of Agriculture, which has been under pressure from scientists both at home and abroad to share more data on the H5N1 bird flu outbreaks in dairy cows, uploaded a large number of genetic sequences of the pathogen late Sunday. Access to the 239 genetic sequences will help scientists assess whether the dangerous virus has acquired mutations that might make it easier for it to spread to and among mammals, and whether additional changes have been seen as it moves from cow to cow a

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Inside J&J’s strategy to de-gender clinical trials

PharmaVoice

Mark Wildgust, vice president of global medical affairs for J&J's oncology division, shares strategies for making clinical trials gender- and trans-inclusive.

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Novartis names ex-BMS CEO Caforio as chair amid strong Q1

pharmaphorum

Novartis has proposed ex-BMS CEO Caforio as the successor to chair Joerg Reinhardt when he steps down next year, as it posts a strong set of Q1 results

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STAT+: In a scientific first, researchers use CRISPR base editing to treat liver disease in fetal monkeys

STAT

The ambitious idea of using CRISPR to cure genetic diseases before birth is one step closer to reality. Scientists reported on Monday that they used a form of the technology known as “ base editing ” to alter the DNA of laboratory monkeys in the womb, substantially reducing the levels of a toxic protein that causes a fatal liver disease before the animals had even been born.

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WuXi partnerships at risk as lawmakers target Chinese ties to biopharma

PharmaVoice

Why the legislation could throw a wrench into the supply chain for advanced therapies and how the industry has responded.

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Zydus launches Mirabegron ER tablets in US

Express Pharma

Zydus Lifesciences has launched Mirabegron Extended-Release Tablets, 25 mg in the US market. The company had earlier received final approval from the United States Food and Drug Administration (USFDA) to market Mirabegron Extended-Release Tablets USP 25 mg and 50 mg (USRLD: Myrbetriq Extended-Release Tablets). Zydus is among the first suppliers to launch the generic version of Mirabegron Extended-Release Tablets, USP 25 mg in the US market and is prepared to launch Mirabegron Extended-Release Ta

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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With $75m cash injection, SynOx plans ph3 rare tumour trial

pharmaphorum

Ireland’s SynOx Therapeutics has completed a second-round financing, raising $75 million, as it prepares to take its drug for tenosynovial giant cell tumour (TGCT) into phase 3 trials. TGCT is a rare disease affecting the joints and tendons caused by overproduction of the protein CSF-1, which stimulates the proliferation of various cell types, inflammation, and destruction of the matrix of the joint.

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Hospitals largely keep quiet on maternal care since Dobbs, STAT survey finds

STAT

The Supreme Court decision to overturn Roe v. Wade has transformed not just abortion access but maternal health care across the United States, causing physicians in states with restrictive laws to shift treatment of conditions including ectopic pregnancy and miscarriage. The full scale of the impact, though, has been obscured in a polarized political climate where physicians are often afraid to speak out, or are blocked by their hospitals from talking about their experiences post-Dobbs.

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New patent expiration for Galderma Labs drug SOOLANTRA

Drug Patent Watch

Annual Drug Patent Expirations for SOOLANTRA Soolantra is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from three suppliers.

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Pharmacy First: Top tips for managing acute sore throats

The Pharmacist

CLINICAL UPDATE The Pharmacy First service in England enables pharmacists to diagnose and treat seven specific conditions, which should hopefully reduce some of the current pressures on general practice. This series of guides assumes that pharmacists are familiar with the clinical pathways and requirements for Pharmacy First. The articles explore some key aspects of each […] The post Pharmacy First: Top tips for managing acute sore throats appeared first on The Pharmacist.

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EU approves Pfizer antibiotic for superbug infections

pharmaphorum

Pfizer’s Emblaveo has been approved in the EU with a first-in-class indication in multidrug-resistant (MDR) infections. The drug – a combination of beta-lactam antibiotic aztreonam with beta-lactamase inhibitor avibactam – is the first drug of this type to get a green light from the European Commission to treat serious infections caused by MDR Gram-negative bacteria in adults.

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STAT+: Health care lobbying giants spent big as little got done in Congress

STAT

WASHINGTON — Congress did nothing this spring to rein in how pharmacy benefit managers operate, which is precisely the outcome the industry’s lobbyists wanted. And the PBM industry spent big to get that result, new disclosures show. The Pharmaceutical Care Management Association, the industry’s biggest trade group, spent a whopping 71% more on lobbying in the first three months of this year compared with 2023, increasing its spending from $2.8 million to $4.8 million.

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BioMarin Pharmaceutical gets grant for treatment of adolescent PKU patients using AVPAL variant

Pharmaceutical Technology

Discover how BioMarin Pharmaceutical's patent for PAL variants offers a groundbreaking method to treat PKU in adolescents. Administering AvPAL variants weekly over 50 weeks effectively reduces blood phenylalanine levels.

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Lilly to buy injectable drug plant in manufacturing ramp-up

BioPharma Dive

The acquisition of a Nexus Pharmaceuticals facility in Wisconsin could help Lilly better meet demand for injectable medicines, like those it makes for diabetes and obesity.

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FDA clears ImmunityBio’s bladder cancer drug at 2nd attempt

pharmaphorum

After rejecting ImmunityBio’s Anktiva last year, the FDA has now cleared the drug as a treatment for bladder cancer, making it the biotech's first commercial-stage product

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Opinion: Free med school tuition won’t solve the shortage of primary care physicians

STAT

Last month, nearly 40,000 medical students were accepted into residency programs on “Match Day.” Surrounded by family and friends, these soon-to-be-physicians opened envelopes revealing where they would begin their careers. This moment marked the culmination of a residency match process that requires medical students to make a series of choices and rankings about which medical specialty to practice and at which health system, along with the various lifestyle factors inherent in suc

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Health Canada approves Merck’s KEYTRUDA for gastric cancer treatment

Pharmaceutical Technology

Health Canada has approved Merck’s KEYTRUDA (pembrolizumab), an anti-programmed cell death protein 1 (PD-1) therapy for use in combination with fluoropyrimidine- and platinum-containing-chemotherapy as a first-line treatment for adult gastric cancer patients.

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Bristol Myers taps startup to boost CAR-T production

BioPharma Dive

A partnership with Cellares, worth up to $380 million, is meant to help Bristol Myers speed and scale manufacture of the complex cellular treatments.

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BMS preps for CAR-T growth with $380m Cellares deal

pharmaphorum

Bristol-Myers Squibb has shored up manufacturing of its CAR-T therapies by reserving exclusive capacity wt contract manufacturer Cellares in $380m deal

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STAT+: How a scientific slip-up caused a pregnant woman to get an untested treatment for preterm birth

STAT

Makena, once the only available treatment to prevent preterm birth, has had its share of controversy. A yearslong debate over the drug’s effectiveness led the Food and Drug Administration to withdraw its approval of the product and demand it be pulled from the market after a confirmatory trial couldn’t replicate the results of a key study.

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GS-6212 by Gilead Sciences for Human Immunodeficiency Virus (HIV) Infections (AIDS): Likelihood of Approval

Pharmaceutical Technology

GS-6212 is under clinical development by Gilead Sciences and currently in Phase I for Human Immunodeficiency Virus (HIV) Infections (AIDS).

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On the Go: Pharmacy Solutions for Summer Travel Medications

PioneerRx

The summer is rapidly approaching. From getting ready for graduation ceremonies to preparing for your favorite user conference (hello, Catalyst Connect 2024).

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CSL Vifor offers campaign to mollify EC in antitrust probe

pharmaphorum

CSL Vifor offers a communication campaign to answer EU allegations it disparaged a rival iron deficiency treatment from Pharmacosmos.

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Biden administration finalizes abortion privacy protections

STAT

WASHINGTON — Biden officials are still pressing to shore up abortion protections amid an onslaught of legal challenges, one of which is slated for Supreme Court arguments this week. The Department of Health and Human Services on Monday released a final rule that would put abortion services under the same federal privacy protections as other health care data covered by the Health Insurance Portability and Accountability Act, or HIPAA.

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Alarm over level of discrimination faced by pharmacists with a disability

The Pharmacist

Concerns have been raised over the level of exclusion and discrimination reportedly faced by pharmacists with a disability or long-term condition. The Pharmacists’ Defence Association (PDA) has revealed early findings of its disability discrimination survey, which is designed to gather the workplace experiences of members who have a long-term condition or disability.

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Widening adoption of animal-free reagents for endotoxin testing

European Pharmaceutical Review

The USP Microbiology Expert Committee is due to vote on the proposed Chapter <86> to approve bacterial endotoxin testing using non-animal derived reagents between 21 June and 1 July 2024. Jaap Venema , Chief Science Officer, USP shared with EPR that the chapter is helping to guide manufacturers how to the adopt these methods and provides “a path to wider adoption”.

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Trial reveals mechanisms that contribute to impact of malnutrition and HIV infection

Pharma Times

Severe acute malnutrition is responsible for nearly half of all child deaths globally and affects 17 million children annually

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Opinion: An FDA pathway can accelerate innovation for Duchenne muscular dystrophy

STAT

In human biology, the protein dystrophin is a shining example of Joni Mitchell’s classic line, “you don’t know what you’ve got ’til it’s gone.” Dystrophin stabilizes muscle cells. In its absence, the house of cards comes down. For my 6-year-old son, Charlie, dystrophin will govern how long he lives. And how much dystrophin he has in his body depends on the ability of drug developers to continue improving it with innovation.

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March sees highest number of measles cases yet as outbreak continues to spread

The Pharmacist

March saw the highest number of measles cases yet this year as the outbreak continues to spread around the country. The latest figures from the UK Health Security Agency showed there were 299 laboratory confirmed cases of measles in March. This is higher than the 274 cases seen in January when officials declared a national incident […] The post March sees highest number of measles cases yet as outbreak continues to spread appeared first on The Pharmacist.

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Torbay Pharma: 'We are all about making sterile supply simple'

Outsourcing Pharma

Torbay Pharmaceuticals is a sterile injectable contract manufacturer and licence holder based in Devon, UK. We spoke with CEO Emma Rooth about the company's heritage and how it is striving to support the U.S. market.

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Ipsen signs $1.8bn RNA drug alliance with Skyhawk

pharmaphorum

Ipsen agrees $1.8 bn alliance with Skyhawk Therapeutics focused on RNA-modulating drugs for rare neurological diseases.

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