STAT

FEBRUARY 21, 2023

A bedrock of the U.S. mental health system — a nine-item questionnaire used to spot depression — began not with a doctor, but with a marketing man. Howard Kroplick, now 73 years old and living on Long Island, is obsessed with antique racing cars and, in his storied career in the pharmaceutical industry, crucially urged Pfizer to avoid the word “impotence” when promoting Viagra.

334

334

PharmaVoice

FEBRUARY 21, 2023

The rare disease market is set for major growth in the decade to come, and pharma companies are securing their footholds now.

245

245

ALiEM - Pharm Pearls

FEBRUARY 24, 2023

What is the proposed mechanism for the pictured antidote when used as a pressor for refractory vasoplegic shock? Alpha-1-adrenergic agonist Angiotensin II receptor antagonist Nitric oxide/cyclic GMP pathway inhibition Vasopressin-1 receptor agonist Reveal the Answer Answer 3 – Inhibition along the nitric oxide (NO)/cyclic GMP pathway Background Vasoplegic shock is a maldistribution of blood flow and inadequate oxygen delivery secondary to an abnormally low systemic vascular resistance [1].

Labelling 173

Labelling 173

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 130

Pharmaceutical Companies Pharmaceutical Companies Compounding Drug Development 130

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

FEBRUARY 24, 2023

A classic warning in public health goes like this: “A society that spends so much on health care that it cannot or will not spend adequately on other health enhancing activities may actually be reducing the health of its population.” No nation is as guilty of this practice as the United States, with its extremely high health expenditures alongside abysmal population-level health outcomes.

285

285

PharmaVoice

FEBRUARY 22, 2023

Kristen Fortney, CEO of BioAge Labs, wants to improve the human life span by focusing on the human health span.

246

246

European Pharmaceutical Review

FEBRUARY 24, 2023

University Hospital Erlangen in Germany is the first in the world to use chimeric antigen receptor (CAR) T-cells to successfully treat a patient suffering from a severe case of muscle inflammation (myositis). The researchers noted that risk of developing a very severe form of the autoimmune inflammatory disease is high. The patient who received the CAR T treatment was diagnosed with anti-synthetase syndrome.

Immunity 128

Immunity Immunization Hospitals 128

STAT

FEBRUARY 19, 2023

Watching news reports of the heroic relief efforts underway in Turkey and Syria following the devastating earthquake there, I can imagine the terrible weight of emotional trauma that so many people are experiencing right now because I’ve experienced it myself. A dozen years ago, as a young doctor with a background in emergency medicine, I felt prepared to handle disaster response situations.

258

258

PharmaVoice

FEBRUARY 23, 2023

Despite a court ruling, the FDA is sticking to its narrow orphan drug exclusivity approach. But confusion remains over the policy’s future.

130

130

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.

110

110

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

FEBRUARY 21, 2023

Final draft guidance from NICE ensures people at highest risk will have access to COVID-19 therapies

141

141

STAT

FEBRUARY 21, 2023

This year could shape up to be a historic one for tobacco control — or one in which Big Tobacco accelerates its steady transformation into Big Nicotine. We are hoping for the former, but aren’t betting against the latter. For the last few years, the tobacco industry has publicly endorsed harm reduction. This public health strategy includes efforts designed to reduce, though not eliminate, risks for people who engage in harmful behaviors.

256

256

PharmaVoice

FEBRUARY 21, 2023

A slew of early stage biotechs were forced to shut down last year as the market tanked. Will the trend continue?

147

147

Pharmaceutical Technology

FEBRUARY 22, 2023

Amgen could be the winner of a high-stakes patent spat with Sanofi as tensions run high weeks before the March 27 US Supreme Court hearing. While some courts were previously on Sanofi’s side, it is possible that Amgen’s case could win this time, some legal experts say. However, Sanofi’s side also has significant support, highlighting the dispute’s contentious nature.

104

104

Pharma Times

FEBRUARY 23, 2023

Next phase of Newel Health’s digital therapeutics solution for Parkinson’s disease gains vital grant

131

131

STAT

FEBRUARY 23, 2023

The shouting began soon after my son was born. “We’ve got an inversion!” the doctor yelled to his team. Moments earlier, a nurse had pressed my newborn son against my chest. I bent to kiss his dark curls through my surgical mask, then he and my husband were escorted out of the operating room.

250

250

PharmaVoice

FEBRUARY 24, 2023

With a scientific platform based on muscle biology, the late-stage biotech is addressing cardiovascular and neuromuscular diseases.

130

130

European Pharmaceutical Review

FEBRUARY 21, 2023

Included in this issue of European Pharmaceutical Review : FOREWORD Accelerating drug development David Elder, David P Elder Consultancy RAMAN SPECTROSCOPY Shining a light on Raman for microbiological analysis Tim Sandle, Bio Products Laboratory LIMS Overcoming barriers to capturing data in a laboratory Samantha Kanza, University of Southampton ENVIRONMENTAL MONITORING Endotoxin trends: sustainability, automation and beyond Miriam Guest, AstraZeneca UK REGULATORY INSIGHT UPC opt-out – a strateg

Drug Development 103

Drug Development 103

Pharma Times

FEBRUARY 22, 2023

Research will analyse how Huawei’s wearable technology detects atrial fibrillation in post-stroke patients

123

123

STAT

FEBRUARY 20, 2023

Heather Rendulic yearns to use both hands to fill up her plate at a hotel buffet, or slice up her own steak. She wants to pull her hair into a ponytail. She’s tried to teach her husband, but it always comes out a bit messy. Almost nine years after a stroke paralyzed the left side of her body at age 23, Rendulic sat in a lab at the University of Pittsburgh and used her left hand to cut a steak.

246

246

PharmaVoice

FEBRUARY 22, 2023

The first-time CEO has her sights on addressing thousands of diseases with the company’s tRNA platform.

130

130

European Pharmaceutical Review

FEBRUARY 24, 2023

The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of ruxolitinib cream (Opzelura ) for non-segmental vitiligo with facial involvement in people over 12 years old. “With no centrally approved treatment option currently available in the EU, this positive opinion marks a significant milestone for the vitiligo community,” explained Dr Steven Stein, Chief Medical Officer, Chief Medical Officer, Incyte.

99

99

Pharma Times

FEBRUARY 21, 2023

Boost for effected patients as HEMGENIX receives green light from European Commission

137

137

STAT

FEBRUARY 20, 2023

Dan Brickey was stunned when he learned the news. The cost of the cystic fibrosis medicine that his 2-year-old daughter, Ali, had recently started taking was about to climb from just $180 out of pocket each year to a whopping $43,600 in 2023. The dramatic change was due to a decision by the drug’s manufacturer, Vertex Pharmaceuticals, to slash the amount of financial assistance that it offers to patients this year.

Drug Pricing 246

Drug Pricing 246

PharmaVoice

FEBRUARY 23, 2023

The VP of public affairs at Kyowa Kirin discusses her role in advocating for advocacy.

130

130

PharmExec

FEBRUARY 22, 2023

Sermo and LiveWorld survey of 50+ pharma marketers and 200+ physicians finds that social media plays a major role in influencing perceptions of medications, prescribing Habits, ongoing medical education and professional networking.

98

98

Pharmaceutical Technology

FEBRUARY 22, 2023

The US Food and Drug Administration (FDA) has granted Fast Track designation for Biohaven ’s new anti-myostatin adnectin, taldefgrobep alfa, to treat spinal muscular atrophy (SMA). The new myostatin-targeting biologic investigational agent has been designed for specific binding to myostatin (GDF-8) to reduce overall levels of myostatin. It also works as a receptor antagonist to block myostatin signalling in skeletal muscles.

98

98

STAT

FEBRUARY 23, 2023

TOPEKA, Kan. – When I inquired about cannabis products at a vape shop on the west side of Kansas’ capital city, the employee asked me one question: “Do you have pain, or are you trying to get f—- up?” There were plenty of options for the latter — especially for someone with a sweet tooth. For the chocoholic: “Trips Ahoy” cookies, THC “Snickers,” and “Cookies ‘n’ Cream” flavored chocolate bars.

245

245

Pharmafile

FEBRUARY 22, 2023

The FDA is expected to approve Pfizer’s new respiratory syncytial virus (RSV) vaccine this summer following its acceptance of the company’s fast-track license application for the new product. Pfizer’s jab is administered to pregnant women in the second or third trimester and can protect the infant from RSV, as antibodies triggered by the vaccine are passed on to the foetus, meaning they are protected against RSV from birth until they are around six months old.

Vaccines 98

Vaccines 98

Outsourcing Pharma

FEBRUARY 22, 2023

Father and software engineer, Vincent Keunen combined his personal experience of leukemia and his son's bone cancer with his professional skills to provide all patients with a tool to manage their health information on their smartphone.

98

98

Pharmaceutical Technology

FEBRUARY 20, 2023

The US Food and Drug Administration (FDA) has granted approval for Apellis Pharmaceuticals’ Syfovre (pegcetacoplan injection) to treat geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD). Syfovre has been approved for use in people with GA with or without subfoveal involvement and offers dosing flexibility with a regimen of every 25 to 60 days for patients and physicians.

Adverse Reactions 98

Adverse Reactions Immunity Immunization 98

STAT

FEBRUARY 22, 2023

Stroke risk prediction tools are meant to guide how doctors approach a potentially deadly condition, using factors like heart disease and high blood pressure to get a handle on which patients might benefit from a particular treatment. For years, doctors have used several different algorithms to try to capture the true risk of stroke, including newer models that use machine learning.

Hospitals 245

Hospitals 245

Pharma Times

FEBRUARY 23, 2023

Phase 1/2 research shows that treatment could be very effective against Fabry disease

133

133

Outsourcing Pharma

FEBRUARY 20, 2023

A survey conducted to understand whether supply issues over amoxicillin have persisted in the US found that an overwhelming majority of pharmacists are still struggling to source the commonly-used antibiotic.

98

98

Pharmaceutical Technology

FEBRUARY 21, 2023

Pfizer and BioNTech’s Covid-19 vaccine, Comirnaty, had a phenomenal year with forecast sales of $37bn in 2022. Comirnaty is expected to maintain the sales dominance it saw during the Covid-19 pandemic going into the future, with the average annual sales forecast rising by 19% between H1 and H2 2022, according to GlobalData’s Coronavirus Disease 2019 (Covid-19) Sector Forecast: H2 2022 Global Analyst Consensus Sales Forecast report.

Vaccines 98

Vaccines 98