STAT

JUNE 23, 2023

Father’s Day weekend was anything but calm on Twitter, which erupted as vaccine expert Peter Hotez was challenged online to a debate by podcaster and former reality TV host Joe Rogan. Rogan’s challenge began when Hotez, a professor of pediatrics and molecular virology and microbiology at Baylor College of Medicine and vaccine expert, tweeted his  concern about Rogan’s three-hour interview with longtime anti-vaccine activist  and presidential candidate Robert F.

Vaccines 363

Vaccines 363

PharmaVoice

JUNE 22, 2023

These six Big Pharma companies have ranked among the best places to work for LGTBQ+ equality by the Human Rights Campaign Foundation for over 10 years. Here’s why.

246

246

Pharmaceutical Technology

JUNE 20, 2023

The World Health Organisation (WHO) has granted an emergency use listing (EUL) to SK bioscience’s Covid-19 vaccine, SKYCovione. SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator. Developed using pharmaceutical company GSK’s pandemic adjuvant, the vaccine targets the receptor-binding domain of the SARS-CoV-2 spike protein.

Vaccines 145

Vaccines Pharmaceutical Companies Pharmaceutical Companies 145

BioPharma Dive

JUNE 22, 2023

The conditional clearance for Sarepta’s Elevidys in 4- and 5-year-olds is a milestone for research into the deadly disease, and raises the stakes of an ongoing trial that could prove how well it works.

127

127

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.

STAT

JUNE 23, 2023

Vertex Pharmaceuticals said Friday that, over a year after receiving the company’s stem-cell therapy, two type 1 diabetes patients no longer need to take insulin injections and saw stark reductions in a biological marker of disease.  The results, presented at the American Diabetes Association conference in San Diego, bolstered experts’ hopes that the treatment could provide a functional cure for some patients.

Diabetes 363

Diabetes 363

PharmaVoice

JUNE 20, 2023

The AI revolution is bringing a new era of drug discovery, and the potential for more uses is greater and faster than ever before.

271

271

Pharma Times

JUNE 21, 2023

Candidate is a cancer therapy that has been chemically modified with Avacta’s pre|CISION platform - News - PharmaTimes

136

136

STAT

JUNE 21, 2023

For years, public health guidance about opioid overdoses has been relatively simple: Administer naloxone , then call 911. But the days of simply spraying naloxone into an overdose victim’s nose, then watching that person resume breathing and wake up within minutes, are over.

342

342

PharmaVoice

JUNE 20, 2023

As the fallout of the Aduhelm approval continues, scrutiny of the speedier pathway has increased and the pressure is on to close a key gap in the regulation.

190

190

BioPharma Dive

JUNE 21, 2023

While treated patients appear to be doing better than history suggests they would, mixed findings involving a key surrogate marker perplexed Wall Street analysts and sent shares falling 38%.

117

117

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

Pharma Times

JUNE 22, 2023

ATLX-1088 is regarded as a possible first-in-class human antibody targeting CD33 – a cell surface protein - News - PharmaTimes

117

117

STAT

JUNE 22, 2023

When I was diagnosed with Duchenne muscular dystrophy 20 years ago, there was no hope. The guidance the diagnosing doctor gave my parents was simple: Love your child as much as you can now because he won’t be here very long. That was the inspiration that my mom needed to start CureDuchenne. Her intention — our whole family’s intention — was to cure this disease so no other parents would have to go through the same traumatic prognosis.

332

332

Express Pharma

JUNE 19, 2023

Pharma companies sell their products by representing them to doctors through medical representatives (MRs) and generating prescriptions. These traditional MRs remain the mainstay of a pharma company’s business generation process, even with the emergence of newer modes of connection between healthcare providers and pharma companies, such as digital and omnichannel platforms.

Communication 105

Communication Customer Service 105

BioPharma Dive

JUNE 22, 2023

The cost makes Sarepta’s treatment, called Elevidys, among the most expensive medicines in the world. But company executives said they don’t expect significant insurer pushback.

115

115

Pharmaceutical Technology

JUNE 23, 2023

Psylo and Daiichi Sankyo have signed a sponsored research deal to advance the development of non-hallucinogenic psychiatric therapies.

119

119

STAT

JUNE 21, 2023

Last year, after a string of high-profile trial failures , the Huntington’s disease community got positive news in the form of very early data from an experimental gene therapy for the rare neurodegenerative condition. On Wednesday, however, the company behind the drug released updated figures that were more mixed — even befuddling. The study from Uniqure, a Dutch biotech, randomized early stage Huntington’s patients to receive low-dose treatment, a high-dose treatment, or a

Drug Development 298

Drug Development 298

Pharma Times

JUNE 19, 2023

Partnership will help NHS to prepare for fundamental change, including reducing carbon emissions - News - PharmaTimes

119

119

BioPharma Dive

JUNE 21, 2023

Empress Therapeutics claims its technology allows it to identify chemical drug candidates faster and more reliably. It has $50 million from Flagship to prove it can.

112

112

Express Pharma

JUNE 20, 2023

The vaccine efforts of the COVID-19 pandemic highlighted our knowledge about gaps in the immune system. Reductionist systems, such as genetically identical inbred mice, have long been the choice for immunology research, which focuses on studying the cells, tissues, and organs that make up the immune system. However, the spotlight has shifted to unravelling the complexities of the human immune system.

Immunity 99

Immunity Immunization Vaccines Hospitals 99

STAT

JUNE 21, 2023

The rat kidney was peculiarly beautiful — an edgeless viscera about the size of a quarter, gemstone-like and gleaming as if encased in pure glass. It owed its veneer to a frosty, minus 150-degree Celsius plunge into liquid nitrogen, a process known as vitrification, that shocked the kidney into an icy state of suspended animation. Then researchers at the University of Minnesota restarted the kidney’s biological clock, rewarming it before transplanting it back into a live rat ȁ

295

295

Pharma Times

JUNE 20, 2023

The treatment is administered intravenously prior to surgery, lighting up cancer during surgery - News - PharmaTimes

118

118

BioPharma Dive

JUNE 20, 2023

The company said limitations on "bridging treatment" used to hold cancer in check could be to blame, and is working with the FDA to change the study's protocol.

105

105

Pharmaceutical Business Review

JUNE 21, 2023

Bluebird is seeking approval for treating a rare genetic disease, SCD, in patients aged 12 years and above having a history of vaso-occlusive events. A modified form of the β-globin gene added to lovo-cel produces anti-sickling adult hemoglobin thereby treating the underlying cause of SCD. The BLA includes efficacy data from the HGB-206 study’s Group C cohort including 36 patients with median 32 months of follow-up and HGB-210 study including two patients, each followed for 18 months.

98

98

STAT

JUNE 20, 2023

Employers across the country — from big names like Boeing and UPS to local school systems — pay consulting firms to handle a straightforward task with their prescription drug coverage: Get the best deals possible, and make sure the industry’s middlemen, known as pharmacy benefit managers, aren’t ripping them off with unfair contracts.

Pharmaceutical Manufacturing 295

Pharmaceutical Manufacturing Documentation 295

Pharmaceutical Technology

JUNE 21, 2023

AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 mg tablet) to treat cardiovascular disease. LODOCO is indicated for reducing the risk of stroke, myocardial infarction and cardiovascular death in adults with established atherosclerotic cardiovascular disease (ASCVD) or with multiple risk factors for the disease.

98

98

BioPharma Dive

JUNE 23, 2023

In a memo made public Friday, Peter Marks, head of the agency office that oversees gene therapies, wrote that he disagreed with other reviewers and saw “compelling” evidence to clear Elevidys.

102

102

European Pharmaceutical Review

JUNE 23, 2023

Study data from a major trial has demonstrated RNA CAR-T (rCAR-T) therapy Descartes-08 facilitated significant and long-lasting clinical improvement in generalised myasthenia gravis (gMG). This is the first clinical trial using rCAR-T to treat autoimmunity. It is also the first successful Phase II trial using an engineered cell therapy for autoimmunity.

Chemotherapy 98

Chemotherapy 98

STAT

JUNE 20, 2023

I recently took care of a patient whose medical records included multiple notes about her past open-heart surgery. Only she had never undergone open-heart surgery.

Medical Records 304

Medical Records 304

Pharmaceutical Technology

JUNE 20, 2023

Santhera Pharmaceuticals and Catalyst Pharmaceuticals have signed an exclusive licence and collaboration deal for Santhera’s vamorolone in the US, Canada and Mexico. Catalyst Pharmaceuticals will gain exclusive rights to commercialise vamorolone across the region. The investigational drug candidate vamorolone has a mode of action based on binding to the same receptor as glucocorticoids while changing its downstream activity.

98

98

BioPharma Dive

JUNE 23, 2023

Ahead of Leqembi’s possible full approval next month, the agency released details emphasizing how the required registry to track patient outcomes will be free and easy to use.

102

102

The Pharmacist

JUNE 22, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) will consider whether further action is needed after a coroner warned doctors were unaware of a rare risk of suicide linked to the commonly used antibiotic ciprofloxacin. A prevention of future deaths report said that a respected and experienced consultant cardiologist, who had recently retired, died by […] The post MHRA investigating ciprofloxacin suicide risk awareness appeared first on The Pharmacist.

96

96

STAT

JUNE 22, 2023

The Food and Drug Administration granted conditional approval Thursday to the first gene therapy for Duchenne muscular dystrophy. Regulators restricted the treatment to younger patients, with additional data required to broaden its use. The gene therapy, called Elevydis, is made by Sarepta Therapeutics. The company will charge $3.2 million for the treatment, making it the U.S.

275

275

Pharmaceutical Technology

JUNE 19, 2023

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. The FDA will make an approval decision by the new Prescription Drug User Fee Act (PDUFA) target action date of 16 September 2023. The reason for this review extension was undisclosed in the announcement.

98

98

BioPharma Dive

JUNE 20, 2023

Joining larger CDMOs like Lonza and Catalent, a new group of companies aims to capitalize on persistent bottlenecks in producing complex genetic treatments.

108

108

Pharma Times

JUNE 23, 2023

The organisations will focus on the delivery of clinical trials which concentrate on rare cancers - News - PharmaTimes

113

113