STAT

AUGUST 12, 2024

If you twirl a bottle of alcohol and squint, you might see a text box with a warning. Usually in black and white, with letters two to three millimeters high, it reads: GOVERNMENT WARNING: (1) According to the Surgeon General, women should not drink alcoholic beverages during pregnancy because of the risk of birth defects. (2) Consumption of alcoholic beverages impairs your ability to drive a car or operate machinery, and may cause health problems.

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Labelling 362

PharmaVoice

AUGUST 12, 2024

Deals driven by obesity meds are fueling an M&A comeback.

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STAT

AUGUST 12, 2024

When the FDA learned that a testing facility in India had submitted fraudulent data for more than 400 drugs (most of them generics), the agency should have withdrawn them from the market. Instead, it has allowed these drugs to continue to be prescribed and distributed for at least a year as the pharmaceutical companies retest them for equivalency to the original brand-name drugs.

Pharmaceutical Companies 357

Pharmaceutical Companies Pharmaceutical Companies 357

BioPharma Dive

AUGUST 12, 2024

Editors at Psychopharmacology cited "unethical conduct" that the study authors didn't disclose when submitting the papers. Lykos Therapeutics says it filed a complaint with a third party to review the way the journal came to its decision.

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STAT

AUGUST 12, 2024

Pharmacy benefit managers have been in the crosshairs of late, as the focus of media scrutiny, government investigations and reports, and proposed federal legislation. A few recent examples make the point: A New York Times story in June 2024 bore the headline, “Pharmacy benefit managers are driving up drug costs for millions of people, employers and the government.

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Drug Pricing 337

Pharmaceutical Commerce

AUGUST 12, 2024

In this part of his Pharma Commerce video interview, Josh Marsh, Vice President and General Manager of Cardinal Health Sonexus Access and Patient Support, discusses the impact technology has in relation to patients sticking to their medication plan.

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BioPharma Dive

AUGUST 12, 2024

The clearance of Yorvipath for hypoparathyroidism was some time coming for Ascendis, which had resubmitted after receiving a rejection last year.

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STAT

AUGUST 12, 2024

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Morning. A hard weekend for those backing MDMA-assisted psychotherapy: First, the FDA rejects a treatment from Lykos Therapeutics. Now a journal is retracting three MDMA papers, citing data integrity issues. Also, a nasal epinephrine spray gets an FDA approval, and more.

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Drug Pricing Drug Development 294

Express Pharma

AUGUST 12, 2024

Atul Bioscience, a 100 per cent subsidiary company of Atul, received Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its manufacturing facility situated in Ambernath, Maharashtra. The EIR was issued post the last inspection of the facility conducted from May 06, 2024, to May 10, 2024 which concluded with zero FDA 483 observations.

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STAT

AUGUST 12, 2024

Want to stay on top of health news?  Sign up  to get our Morning Rounds newsletter in your inbox. It’s Brittany subbing for Theresa this fine Monday. Thank you for all of the excellent song recommendations over the weekend. If you want to check out my road trip playlist, you can find it here.

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Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

BioPharma Dive

AUGUST 12, 2024

Results from a Phase 3 study could help Pfizer broaden use of its vaccine Abrysvo to younger adults whose medical history puts them at higher risk.

Vaccines 109

Vaccines 109

Express Pharma

AUGUST 12, 2024

Novo Nordisk Education Foundation (NNEF), a non-profit organisation set up by Novo Nordisk India, signed a Memorandum of Understanding (MoU) with Rabindranath Tagore (RNT) Medical College, Udaipur to establish a ‘Sickle Cell Wellness Hub’ dedicated to people living with sickle cell disease (SCD). The MoU was signed between Dr Vipin Mathur – Principal & Controller, RNT Medical College and Vikrant Shrotriya – Managing Trustee, Novo Nordisk Education Foundation.

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Hospitals 104

World Pharma News

AUGUST 12, 2024

Pfizer Inc. (NYSE: PFE) today announced positive top-line safety and immunogenicity results from substudy B of the ongoing pivotal Phase 3 clinical trial ( NCT05842967) MONeT (RSV I Mmunizati ONStudy for Adul Ts at Higher Risk of Severe Illness), evaluating two doses of ABRYSVO vaccine in immunocompromised adults aged 18 and older at risk of developing severe respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD).

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Vaccines 96

Pharmaceutical Technology

AUGUST 12, 2024

As antibody drug conjugate (ADC)-centred deals dominate the oncology space, biotechs are using newer targets and linkers to differentiate themselves.

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pharmaphorum

AUGUST 12, 2024

Explore how the recent and upcoming elections may impact the field of life sciences and medical technology. Stay informed about the intersection of politics and health advancements.

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The Pharmacist

AUGUST 12, 2024

Prescribers must get the support they need to train, supervise and support trainees as designated prescribing practitioners (DPPs), the Royal Pharmaceutical Society (RPS) has urged. This comes as the RPS and the National Pharmacy Association (NPA) have together published a roundtable report discussing the barriers and solutions to providing prescribing training for pre-registration pharmacists.

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pharmaphorum

AUGUST 12, 2024

Three controversial decisions by NICE on NHS use of new multiple myeloma therapies are heading for the end of comment and appeals processes.

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Outsourcing Pharma

AUGUST 12, 2024

In a landmark move for the pharmaceutical industry, PLAIO, a pioneering Icelandic tech firm, has secured â4.3 million in an oversubscribed funding round to accelerate its AI-driven sales and operations planning platform designed specifically for the pharmaceutical sector.

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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.

Pharma Times

AUGUST 12, 2024

A second dose of the vaccine lowered the incidence of conditions such as heart attack or stroke

Vaccines 112

Vaccines 112

The Pharmacist

AUGUST 12, 2024

The president of the UK Black Pharmacist Association (UKBPA) has welcomed the change in proposed training routes for internationally qualified pharmacists. This comes as the General Pharmaceutical Council (GPhC) has scrapped its proposals for a three-route system that had come under fire for potentially being unfair. Instead, the GPhC has now proposed a single, one-year […] The post UKBPA welcomes single route to register internationally qualified pharmacists appeared first on The Pharmaci

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Pharma Times

AUGUST 12, 2024

Bowel cancer was the most common cancer to be identified in both men and women

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Outsourcing Pharma

AUGUST 12, 2024

In a blow to millions of Americans battling post-traumatic stress disorder (PTSD), Lykos Therapeutics announced today that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for its new drug application (NDA) for midomafetamine capsules.

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Pharmacy Management

pharmaphorum

AUGUST 12, 2024

MSD adds a bispecific antibody for blood cancers and autoimmune diseases to its pipeline via a $1.3bn licensing deal with Curon Biopharma.

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Pharmaceutical Commerce

AUGUST 12, 2024

A lack of access could shut out patients in need of maintenance drugs for complex conditions.

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pharmaphorum

AUGUST 12, 2024

ARS Pharma gets FDA approval for epinephrine nasal spray neffy, the first needle-free alternative to EpiPen-style autoinjectors for serious allergic reactions.

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FDA Law Blog: Biosimilars

AUGUST 12, 2024

By Sara W. Koblitz — In the world of patent term extensions, every day considered part of the regulatory review period is important, as that day—either in whole or in part—gets added back to the patent upon approval of the product. In the veterinary world, where rolling applications are common, the testing phase is usually particularly important because the review phase, which starts only when the last component of the rolling New Animal Drug Application (NADA)—called the Administrative NADA—is

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pharmaphorum

AUGUST 12, 2024

BiVictriX is the latest UK biotech to say it wants to cancel its AIM-listed shares and go private in pursuit of better financing opportunities.

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European Pharmaceutical Review

AUGUST 12, 2024

Merck (MSD outside of the US and Canada) has agreed to acquire a novel biologic for B-cell associated diseases, from the biotech Curon Biopharmaceutical. CN201 is a novel CD3xCD19-targeting T-cell-engager bispecific antibody. Through the agreement, Merck, through a subsidiary, will acquire worldwide rights, for a total of $700 million. Curon stated that it will be eligible for up to $600 million in milestone payments for CN201.

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Research Laboratories Chemotherapy Drug Development 59

pharmaphorum

AUGUST 12, 2024

Journal retracts three articles on MDMA-assisted psychotherapy, shortly after FDA blocks approval of @Lykos_PBC's therapy for PTSD

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Pharmaceutical Business Review

AUGUST 12, 2024

Enzeevu is designed to improve and maintain visual acuity in patients suffering from nAMD, a condition that is a primary cause of vision impairment among individuals over 50 years. Enzeevu’s active component is aflibercept. Aflibercept is a recombinant fusion protein that attaches to vascular endothelial growth factor A (VEGF-A) and placental growth factor (PlGF), preventing aberrant vessel development.

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Biosimilars 59

BioPharma Dive

AUGUST 12, 2024

Technology emerging from Yale researcher Craig Crews’ labs will be used to target prostate and breast cancer in early clinical trials.

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Pharmaceutical Commerce

AUGUST 12, 2024

The latest news for pharma industry insiders.

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