European Pharmaceutical Review

FEBRUARY 14, 2023

The COVID-19 pandemic led to an unparalleled paradigm shift in the use of and the incorporation of new technologies into our workflows. This was particularly apparent in academia and the pharmaceutical industry, where we have seen words such as Teams and Zoom becoming part of our new lexicon of language for meetings. Now we reach for these types of online meetings without a second thought, due to the clear productivity benefits they provide over real in-person meetings. 1 However, notwithstandin

128

128

Pharmafile

FEBRUARY 13, 2023

Mumbai-based pharma company, Sun Pharma, has announced that it is recalling over 34,000 bottles of a generic drug, Diltiazem Hydrochloride, from the US market. The drug is used for treating high blood pressure, angina and some types of irregular heartbeat. This recall follows the FDA’s Enforcement Report, which saw “failed impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.

FDA 115

FDA Communication 115

PhRMA

FEBRUARY 16, 2023

Did you know that insurance companies use middlemen — known as pharmacy benefit managers (PBMs) — to decide what medicines people can get and what people pay out of pocket for those medicines?

Insurance 303

Insurance 303

Drug Topics

FEBRUARY 15, 2023

Viruses are known to precipitate autoimmune diseases, but the link between COVID-19 and autoimmune conditions requires additional research.

266

266

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

FDA

STAT

FEBRUARY 24, 2023

WASHINGTON — Nearly three weeks after a train derailed in East Palestine, Ohio, spewing toxic chemicals into the air, water and soil, Biden officials are racing to find answers on how the disaster happened. But it’s also unclear what happens next for thousands of Ohioans who could now be sick — and who covers their care. Ohio lawmakers from both parties have already demanded that Biden health officials step up their response and ensure health care through an obscure provisio

145

145

Fierce Pharma

FEBRUARY 3, 2023

J&J's pharma group quietly works through global overhaul, with layoffs expected to reach multiple countries mbayer Fri, 02/03/2023 - 09:29

145

145

Fierce Healthcare

FEBRUARY 11, 2023

Doximity rolls out beta version of ChatGPT tool for docs aiming to streamline administrative paperwork hlandi Sat, 02/11/2023 - 05:02

145

145

PhRMA

FEBRUARY 23, 2023

State legislative sessions across the country are in full swing, and many state officials have made lowering the cost of medicine for patients a top priority. If policymakers are serious about addressing high out-of-pocket costs for patients, they should start by taking steps to finally hold pharmacy benefit managers (PBMs) accountable.

Insurance 280

Insurance 280

Drug Topics

FEBRUARY 1, 2023

Geographical data could potentially yield insight on racial and ethnic health disparities in the United States. An analysis of the large dataset could help identify any potential causes for observed inequities.

234

234

STAT

FEBRUARY 17, 2023

One day last fall, Kiran’s period cramps became so painful they woke her up from a nap. The 19-year-old took some ibuprofen, but found little relief. “The pain was so bad, it felt like someone was punching me,” said Kiran, who asked to be referred to by only her first name for privacy. It felt “like I was giving birth.

145

145

Fierce Pharma

FEBRUARY 24, 2023

Moderna pays US government $400M 'catch-up payment' under new COVID-19 vaccine license esagonowsky Fri, 02/24/2023 - 09:18

Vaccines 145

Vaccines 145

European Pharmaceutical Review

FEBRUARY 21, 2023

The UK medicinal cannabis sector has witnessed important regulatory advances in recent years. After the substance became legal in the UK in 2018, pharmaceutical companies have faced numerous obstacles to attain a fairer position in the industry. Crucially, January 2023 marked a key moment: the Medicines and Healthcare products Regulatory Agency (MHRA) granted Celadon Pharmaceuticals the first good manufacturing practice (GMP) registration since legalisation in 2018 for high Δ9-tetrahydrocannabin

Pharmaceutical Companies 128

Pharmaceutical Companies Pharmaceutical Companies Compounding 128

The Guardian - Pharmaceutical Industry

FEBRUARY 13, 2023

Appetite suppressant Wegovy, popular with celebrities, seen as breakthrough treatment but not permanent remedy Weekly weight-loss jabs that are popular with celebrities will soon be made available through high street chemists in England, despite controversy over their use. Many people struggle to tackle obesity through diet and exercise alone as they often find they regain the weight that they lose.

121

121

The People's Pharmacy

FEBRUARY 23, 2023

In this week’s episode, find out what everyone gets wrong about weight loss. Why don’t diet and exercise work very well? Do official guidelines and weight loss drugs offer a clearer path to success? Health Consequences of Excess Weight: With nearly three-fourths of American adults either overweight or obese, we can’t ignore the problem any longer. For decades, people have acted as though packing on extra pounds was simply a matter of poor willpower. “Eat less and exercise more” is th

119

119

Drug Topics

FEBRUARY 6, 2023

Artificial intelligence has the potential to revolutionize and improve medicine. However, in order for widespread implementation, certain challenges and obstacles must first be overcome.

201

201

STAT

FEBRUARY 15, 2023

In an unexpected shift, Moderna has decided not to ask Americans to pay for its Covid-19 vaccine, a move that follows intense criticism over initial plans to charge $110 to $130 per dose after the company pivots from government contracts to commercial distribution. The vaccine maker released a brief statement that it “remains committed” to ensuring everyone in the U.S. has access to its Covid-19 shot, regardless of whether they have health insurance coverage.

Vaccines 145

Vaccines Insurance Coverage Insurance 145

The Checkup by Singlecare

FEBRUARY 13, 2023

Lots of people love the idea of taking something natural to improve their health. For example, the idea of taking a supplement that could improve their blood pressure and reduce their chances of heart attack or cardiovascular disease may be very appealing. But how effective–and safe–is this strategy? Before you decide to start taking any supplements for their alleged antihypertensive effects, it’s important to understand what those supplements can and can’t do.

FDA 119

FDA Mayo Clinic Labelling 119

Pharmafile

FEBRUARY 8, 2023

Scottish biotech company ScotBio has announced that it has seen “promising initial results” from its attempts to extract a cure for the common cold from algae. The Livingston-based company is assessing how waste molecules from spirulina, an algae often consumed as a superfood, could be used as a cure for the common cold, COVID-19 and various other viruses.

Communication 117

Communication 117

Pharmaceutical Technology

FEBRUARY 24, 2023

On December 20, 2022, the World Health Organization (WHO) updated its recommendations for cervical cancer vaccines in a bid to boost vaccination coverage. The WHO now says that a one-dose schedule for girls ages 9–14 years adequately protects against human papillomavirus (HPV), and more specifically, the HPV 16 and HPV 18 strains. The insights and amendments came following findings from a meeting held by WHO’s independent expert advisory group in April 2022.

Vaccines 116

Vaccines Medical Schools Immunization Hospitals 116

Fierce Pharma

FEBRUARY 15, 2023

GSK was warned repeatedly about Zantac impurity but played down risks: Bloomberg esagonowsky Wed, 02/15/2023 - 09:02

140

140

Drug Topics

FEBRUARY 16, 2023

Nearly 40 million people in the United States suffer from migraine, with the World Health Organization classifying migraine as 1 of the 10 most disabling medical illnesses.

201

201

STAT

FEBRUARY 16, 2023

Matt Fitzgerald used to bike up and down 3,500 feet through the Santa Ana Mountains on three-hour rides just for fun. Now, nine months after being infected with SARS-CoV-2, the virus that causes Covid-19, he can’t muster walking on flat surfaces for 20 minutes without days of exhaustion. “My long Covid life remains terrifying,” he told me.

145

145

European Pharmaceutical Review

FEBRUARY 13, 2023

Results from Phase III study KarMMa-3, showed chimeric antigen receptor (CAR) T-cell therapy Abecma (idecabtagene vicleucel) more than tripled progression-free survival compared with standard care for triple-class exposed multiple myeloma (MM). Abecma is the first and only CAR T-cell therapy to demonstrate superiority over standard regimens for this indication in a randomised, controlled Phase III trial.

Chemotherapy 113

Chemotherapy FDA Labelling 113

Fierce Healthcare

FEBRUARY 16, 2023

Senators question why PBMs 'even exist' in heated hearing amid push for reform rking Thu, 02/16/2023 - 14:49

144

144

Pharmaceutical Technology

FEBRUARY 3, 2023

Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. On January 18, Janssen, a Johnson & Johnson (J&J) subsidiary, stated that its vaccine was not effective in preventing HIV infections. This marks the second time one of Janssen’s HIV vaccines failed after another showed disappointing results in the Phase IIb Imbokodo trial in August 2021.

Vaccines 117

Vaccines Immunization 117

Fierce Pharma

FEBRUARY 14, 2023

Pfizer CEO's texts with European Commission chief trigger new NYT lawsuit kdunleavy Tue, 02/14/2023 - 10:29

145

145

Drug Topics

FEBRUARY 7, 2023

According to adjusted analyses, vitamin D reduced the risk of diabetes by 15% with a 3-year absolute risk reduction of 3.3%.

201

201

STAT

FEBRUARY 1, 2023

A recent study and accompanying news story in the preeminent journal Nature provocatively concludes that disruptive innovation in science has dramatically and mysteriously declined 90% since 1945. The study has prompted a wave of news coverage and tweets decrying the apparent languishing of modern science. We feel that the authors make interesting observations on publishing trends, but their conclusions seem to be quite disconnected from the valuable and transformative innovations that benefit h

145

145

The People's Pharmacy

FEBRUARY 9, 2023

In this week’s episode, our guest explains why treating hypothyroidism isn’t always as simple as it seems. He is a leading researcher on questions relating to thyroid hormones. What Is Hypothyroidism? Hypothyroidism, a condition in which the thyroid gland doesn’t make enough thyroid hormone, is one of the most common hormonal disorders. It was first identified near the end of the 19th century but is far more widely recognized now.

Immunization 111

Immunization 111

Drug Store News

FEBRUARY 16, 2023

The fudgy oat milk-based frozen dessert bars are available in four flavors — fudge n’ vanilla crunch, double chocolate fudge, fudge n’ caramel crunch and mint n’ fudge chip.

111

111

Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The non-binding draft guidance gives insight into the agency’s current outlook and recommendations for standard and expedited programs in oncology.

Dosage 115

Dosage FDA Pharmaceutical Companies Pharmaceutical Companies 115

Fierce Healthcare

FEBRUARY 24, 2023

Major coalition of health groups aims to combat health misinformation rking Fri, 02/24/2023 - 11:17

145

145

Drug Topics

FEBRUARY 13, 2023

Technology can streamline—and make safer—processes like medication reconciliation.

201

201

STAT

FEBRUARY 16, 2023

Akin Akinc was scouring his email spam box last summer, looking for a missing message, when he stumbled across an unexpected email from a quite recognizable name: Feng Zhang. Zhang, one of the leading scientists in the groundbreaking field of genetic editing, had reached out two days prior to discuss a new company he was working on. Since helping to discover CRISPR-Cas9 — often referred to as molecular scissors that can cut into the genome and edit DNA — Zhang has founded at least

142

142

Fierce Pharma

FEBRUARY 28, 2023

FDA turns down Cytokinetics’ once-promising heart failure drug omecamtiv kdunleavy Tue, 02/28/2023 - 18:55

FDA 140

FDA 140

Drug Store News

FEBRUARY 8, 2023

CVS Health will acquire Oak Street Health in an all-cash transaction at $39 per share, representing an enterprise value of approximately $10.6 billion.

119

119