STAT

APRIL 23, 2024

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.

363

363

PharmaVoice

APRIL 19, 2024

Where Amylyx ultimately failed in ALS, it could prevail in a rare disease. The doctor leading this research explains why.

299

299

Express Pharma

APRIL 22, 2024

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.

Drug Pricing 105

Drug Pricing Diabetes Vaccines 105

BioPharma Dive

APRIL 18, 2024

It’s “early innings” in the obesity drug race, said Metsera CEO Clive Meanwell, whose company has acquired a portfolio of medicines it aims to test in combination.

124

124

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.

pharmaphorum

APRIL 22, 2024

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.

Pharmaceutical Companies 100

Pharmaceutical Companies Pharmaceutical Companies 100

STAT

APRIL 21, 2024

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

363

363

Express Pharma

APRIL 22, 2024

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

105

105

BioPharma Dive

APRIL 18, 2024

The start of a so-called rolling review formally begins an FDA evaluation of a closely watched drug that’s important to the biotech’s future, but faces questions about its sales potential.

119

119

Drug Patent Watch

APRIL 21, 2024

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.

105

105

STAT

APRIL 22, 2024

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.

Packaging 350

Packaging Hospitals 350

Advertisement

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.

Pharmacy Management

Pharmaceutical Technology

APRIL 18, 2024

Outrun Therapeutics announced its launch with $10m seed funding to advance a protein stabilisation pipeline focused on E3 ligase inhibitors.

126

126

pharmaphorum

APRIL 17, 2024

Discover how AI is transforming medical communications and reshaping the future of healthcare. Learn about the latest trends, technologies, and advancements in this rapidly evolving field.

Communication 108

Communication 108

BioPharma Dive

APRIL 18, 2024

Analysts had low expectations for Cerevel’s drug tavapadon, which was something of an afterthought in AbbVie’s proposed buyout of the biotech.

122

122

The Guardian - Pharmaceutical Industry

APRIL 18, 2024

Elizabeth Hanna says she was fired by the American Diabetes Association after refusing to approve recipes heaped with the additive made by a major donor Elizabeth Hanna had a simple job: help people with diabetes figure out what to eat. Anyone with common sense knows this should probably not entail foods that might increase people’s risk of getting diabetes.

Diabetes 110

Diabetes 110

STAT

APRIL 22, 2024

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.

Hospitals 355

Hospitals 355

Pharmaceutical Technology

APRIL 22, 2024

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.

94

94

Express Pharma

APRIL 18, 2024

Semaglutide (gOzempic), which is used to improve glycemic control in adults with type-2 diabetes Biocon announced the signing of an exclusive licensing and supply agreement with Biomm S.A., a specialty pharmaceutical company in Brazil, for the commercialisation of its vertically integrated drug product, Semaglutide (gOzempic), which is used to improve glycemic control in adults with type-2 diabetes.

Diabetes 104

Diabetes Biosimilars Pharmaceutical Companies Pharmaceutical Companies 104

BioPharma Dive

APRIL 19, 2024

The new label for Alecensa makes it the first targeted treatment available after surgery for people with ALK-positive lung tumors, who are at high risk for brain metastases.

Labelling 110

Labelling 110

PioneerRx

APRIL 23, 2024

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

90

90

STAT

APRIL 22, 2024

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.

295

295

Pharmaceutical Technology

APRIL 22, 2024

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.

Chemotherapy 94

Chemotherapy 94

pharmaphorum

APRIL 17, 2024

Sage Therapeutics has suffered another disappointment after deciding that it will have to drop the Parkinson’s programme for key pipeline drug dalzanemdor after it showed no benefit in a phase 2 trial. The oral positive allosteric modulator (PAM) of the NMDA receptor is being investigated to see if it can counteract mild cognitive impairment in neurodegenerative disorders, and the PRECEDENT trial in Parkinson’s is the first major readout from the drug programme.

106

106

BioPharma Dive

APRIL 22, 2024

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.

Diabetes 96

Diabetes 96

The Pharmacist

APRIL 22, 2024

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.

89

89

STAT

APRIL 18, 2024

In the chaotic first few months of the Covid-19 pandemic, stores faced shortages of all kinds — toilet paper, canned food, and especially, cleaning supplies. With everyone scrubbing their groceries, mail, even library books, good luck finding antibacterial wipes or disinfectant sprays back then. That’s because public health advice in early 2020 focused on sanitizing surfaces, not protecting against a virus that could be spread through the air.

363

363

European Pharmaceutical Review

APRIL 22, 2024

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”.

88

88

Outsourcing Pharma

APRIL 22, 2024

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.

88

88

BioPharma Dive

APRIL 22, 2024

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

101

101

Drug Patent Watch

APRIL 23, 2024

Drug repurposing, or identifying new therapeutic uses for existing drugs, is gaining significant momentum as a promising approach to accelerate drug development and reduce costs.

Drug Development 82

Drug Development 82

STAT

APRIL 18, 2024

As two former secretaries of Health and Human Services, we are all too familiar with the struggle of finding narrow openings for bipartisanship. Despite our different approaches, we believe that addressing health care costs is a truly bipartisan issue. To be serious about creating access for people to the best possible care, that care must be affordable for patients and taxpayers.

363

363

pharmaphorum

APRIL 23, 2024

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.

82

82

Pharmaceutical Technology

APRIL 19, 2024

The US Food and Drug Administration (FDA) has granted fast-track designation to Bayer subsidiary Asklepios BioPharmaceutical’s (AskBio) investigational gene therapy AB-1002, aimed at treating congestive heart failure (CHF).

98

98

The Pharmacist

APRIL 22, 2024

The Department of Health and Social Care (DHSC) is looking to address ‘any loopholes’ in prescribing practices following a major review into gender identity services for children and young people, the pharmacy minister has said. This includes working with the General Pharmaceutical Council (GPhC) to ‘define the dispensing responsibilities’ of pharmacists providing private prescriptions, Dame […] The post DHSC to address ‘any loopholes’ in prescribing practices following Cass Review appeare

Online Pharmacies 87

Online Pharmacies 87

Pharmaceutical Commerce

APRIL 19, 2024

In an interview with Pharma Commerce Editor Nicholas Saraceno, Niklas Adamsson, COO, Environtainer, suggests how to improve visibility and risk management for cold chain shipping.

96

96

STAT

APRIL 22, 2024

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.

HIPAA 311

HIPAA 311