Sat.Jul 02, 2022 - Fri.Jul 08, 2022

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FDA Accepts Aflibercept sBLA for Treatment of Diabetic Retinopathy

Pharmacy Times

If approved, the 16-week dosing regimen could offer certain individuals a potentially longer treatment interval and physicians with greater flexibility to individualize treatment.

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Pharma’s spend on AI in drug discovery ‘could top $3bn by 2025’

pharmaphorum

The pharmaceutical industry is increasingly relying on artificial intelligence to power its drug discovery and development efforts, and its spend in this area has created a multibillion-dollar market for AI technologies. That’s the conclusion of a GlobalData report , which notes that AI is being used to enhance computer-aided drug design (CADD) in a bid to reduce the time and costs involved in getting a new drug to market.

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Controlling contamination by material transfer

European Pharmaceutical Review

Ensuring potential microbial contaminants are not transferred into cleanroom environments is a key aspect of risk mitigation strategies. In a review, pharmaceutical microbiologist and contamination control expert Tim Sandle, reviewed several methods of material transfer, listing the decontamination methods based on efficacy and commenting on their weaknesses. .

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Is biotech facing a long bear market?

Pharmaceutical Technology

Talks of a bear market in the biotech sector do not seem to pass, with news of companies falling into administration and layoffs becoming a recurrence. Just last week, trading for 4D Pharma , a British biotech, was suspended on the London Stock Exchange’s Alternative Investment Market , and the company will be delisted from NASDAQ on July 7. Elsewhere, San Diego, California-based Heron Therapeutics announced restructuring and layoffs for 34% of its workforce.

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Position Your Pharmacy for Expansion

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.

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Expert: FDA Announcement of Pharmacists’ Prescribing Authority for COVID-19 Antiviral Paxlovid ‘Is Pharmacy’s Moment’ to Seize the Path to Provider Status

Pharmacy Times

David Pope, PharmD, CDE, the EVP of Innovation and Industry Relations at OmniSYS, discusses the FDA’s announcement updating pharmacists’ prescriptive authority for the COVID-19 antiviral Paxlovid.

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AstraZeneca agrees $1.3bn deal to buy oncology player TeneoTwo

pharmaphorum

AstraZeneca has signed a deal to buy US biotech TeneoTwo in a deal worth up to $1.27 billion that will boost its position therapies for haematological cancers. The big pharma is paying $100 million upfront for the company, and offering up to $805 million in milestone payments if TeneoTwo’s drug candidates meet development objectives, plus up to $360 million if they hit sales targets.

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GSK acquires US-based Sierra Oncology for $1.9bn

Pharmaceutical Technology

GlaxoSmithKline (GSK) has completed the acquisition of all outstanding shares of US-based Sierra Oncology in a deal totalling $1.9bn (£1.6bn), in cash. In April this year, GSK entered an agreement for the acquisition of Sierra Oncology for $55 per share. The conclusion of the deal comes after the shareholders of Sierra Oncology approved the takeover on 29 June this year.

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Research Shows Supporting Gut-Lung Axis Can Prevent Lung Disease

Pharmacy Times

People have been taking probiotics to support digestive health for centuries, but researchers in the pulmonary field have turned their attention toward how microbiome science can be used to support the lungs.

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Partners come on board GSK’s plan for Stevenage life science hub

pharmaphorum

GSK’s recently-unveiled plan to develop a bioscience cluster close to its main R&D site in Stevenage, UK, has moved closer to fruition, now that the first partners have joined the initiative. The asset management arm of Swiss back UBS has formed a joint venture with property developer Reef Group that will develop the 33-acre campus in Stevenage, Hertfordshire.

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Pfizer to reach carbon net-zero by 2040

European Pharmaceutical Review

After more than 20 years of environmental action, Pfizer has committed to further reduce its greenhouse gas (GHG) emissions and aims to achieve the voluntary Net-Zero Standard by 2040 – a full 10 years ahead of the standard’s proposed timeline. To achieve these goals, Pfizer aims to decrease its GHG emissions by 95 percent and its value chain emissions by 90 percent from 2019 levels by 2040.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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Russia’s focus on domestic pharma production could shield it from sanctions’ effects

Pharmaceutical Technology

Russia is an already insular country and its worldview has tended to be self-contained, but this has hardened in the face of recent sanctions and counter-sanctions imposed during the war with Ukraine. Compared with other emerging pharmaceutical markets (such as India and China, covered in previous Emerging Market Outsourcing Reports), Russian facilities lack many US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals, meaning Russian manufacturing is more focused on

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5 Ways to Bridge Communication Problems Between Pharmacists, Physicians to Improve Medication Management

Pharmacy Times

Survey results show 40% of health care leaders believe a lack of communication between prescribers and pharmacists is preventing the successful management of patients’ medications.

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FDA backs pharmacist prescribing of Paxlovid for COVID

pharmaphorum

Some patients with COVID-19 will be able to get easier access to Pfizer’s oral antiviral therapy Paxlovid, after the FDA ruled that pharmacists would be able to prescribe the drug. The regulator has revised the emergency use authorisation (EUA) for Paxlovid (nirmatrelvir and ritonavir) to allow state-licensed pharmacists to prescribe the drug to patients, providing they can provide recent health records and a list of current medicines they are taking.

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What can we learn from contamination control failures?

European Pharmaceutical Review

Inadequate investigations and failure to follow standard operating procedures (SOPs) are some of the most common causes for regulatory warning letters in companies, according to Jeanne Moldenhauer, Vice President of Excellent Pharma Consulting. However, she notes that useful information for assessing risks in your facility and preparing for upcoming inspections can be gleaned from other’s warning letters and regulatory inspection observation reports, such as FDA 483.

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5 Reasons to Upgrade Your Pharmacy Management Software

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.

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Brii Bio acquires Vir’s antibody rights for Hepatitis B in Greater China

Pharmaceutical Technology

Brii Biosciences (Brii Bio) has exercised an option for the acquisition of exclusive development and marketing rights for Vir Biotechnology’s investigational antibody, VIR-3434, for Hepatitis B in Greater China, under a partnership agreement. Following the option exercise, Vir will receive the option exercise fee, regulatory and commercial milestone payments as well as tiered royalties on net product sales from Brii Bio.

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Vitamin D Intoxication from Supplements Both Possible and Harmful, Physicians Report

Pharmacy Times

Hypervitaminosis D, a condition characterized by elevated vitamin D levels, is associated with potential serious health issues, such as psychosis, abdominal pain, vomiting, pancreatitis, and renal failure.

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Ensuring successful digital outreach and retention in atopic dermatitis trials

pharmaphorum

Trial organisers face intense competition to find and recruit eligible patients for atopic dermatitis studies. With more than 500 dermatology clinical trials currently underway, it is often heard that there is a ‘’competition for participants’’. Yet evidence from research studies and a survey with 4,000+ atopic dermatitis patients conducted by Clariness shows that this ‘race to recruit’ is actually not the primary reason for the growing discontinuation rate of atopic dermatitis trials.

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Phase III trial shows lanadelumab reduces HAE attacks in children

European Pharmaceutical Review

Hereditary angioedema (HAE) is a genetic disorder, estimated to affect 1 in 50,000 people. It can lead to painful attacks of oedema (swelling) in various parts of the body, including the abdomen, face, feet, genitals, hands and throat. The main objective of the Phase III SPRING study ( NCT04070326 ) was to evaluate the safety and pharmacokinetics of Takhzyro ® (lanadelumab) – a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein – in HAE patients aged two t

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Brii Bio introduces Covid-19 combination therapy in China

Pharmaceutical Technology

Brii Biosciences and TSB Therapeutics have commercially launched a long-acting neutralising antibody therapy combination, amubarvimab/romlusevimab, for Covid-19 in China. The two non-competing SARS-CoV-2 monoclonal neutralising antibodies, amubarvimab and romlusevimab are obtained from convalesced Covid-19 patients. The company developed these antibodies in partnership with Tsinghua University and the 3rd People’s Hospital of Shenzhen.

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ProAir Digihaler Shows Promise Treating Poorly Controlled Asthma

Pharmacy Times

ProAir Digihaler Inhalation Powder is indicated for the treatment or prevention of bronchospasm in those with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

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Astellas teams up with UK biotech Mogrify on hearing loss project

pharmaphorum

Cell therapy specialist Mogrify has struck a deal with Japanese drugmaker Astellas to look at ways to deploy regenerative medicine to treat hearing loss caused by factors such as chronic exposure to loud noises. The two partners will take an in vivo approach to the problem of so-called sensorineural hearing loss (SNHL) looking at ways to replace sound-detecting hair cells in the inner ear (cochlea) that become damaged in this type of deafness.

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Dave Ross of Seqirus talks 'milestone' influenza vax vote

PharmaVoice

In a unanimous decision, a CDC committee calls for a preferential flu vaccine recommendation for people aged 65 and older for the first time.

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EC approves Novavax’s Covid-19 vaccine CMA expansion for adolescents

Pharmaceutical Technology

The European Commission (EC) has granted approval for the expanded conditional marketing authorization (CMA) of Novavax’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), in the European Union (EU) for adolescents of the age 12 to 17 years. A protein-based vaccine, NVX-CoV2373 is made from the genetic sequence of the SARS-CoV-2 virus’ first strain. The latest development comes after the Committee for Medicinal Products for Human Use of the European Medicines Agency granted a positive recommendation in

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FDA Revises Paxlovid EUA to Allow State-Licensed Pharmacists to Prescribe Drug Under Certain Conditions

Pharmacy Times

Paxlovid treats COVID-19 in adults and children [12 years of age and older weighing at least 88 pounds (40 kg)] with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

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Medical Informatics and Rare Disease: a bridge between two worlds

pharmaphorum

Today’s rare disease landscape comprises of around 7,000 different diseases. With a broad and diverse range of symptoms and severities impacting patients around the world, connecting these individuals with the information and expertise needed to achieve the correct diagnosis can be extremely lengthy and pose a significant barrier to treatment. “As the severity, progress, and treatment potential of rare diseases varies from patient to patient, each condition is going to need to be addressed diffe

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Teva appoints Eric Hughes as head of R&D and Chief Medical Officer

European Pharmaceutical Review

Dr Eric Hughes joins Teva with experience in all phases of drug development at global pharmaceutical companies, most recently Boston-based Vertex Pharmaceuticals, which he joined last year. He will be based out of Teva’s US headquarters in Parsippany, New Jersey. . “Eric brings nearly 20 years of leadership roles with a proven track record in a variety of R&D functions for global pharmaceutical companies, and has a successful record of accomplishment fostering productive collaborations with

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Europe is seeing a hiring boom in pharmaceutical industry data analytics roles

Pharmaceutical Technology

Europe was the fastest growing region for data analytics hiring among pharmaceutical industry companies in the three months ending May. The number of roles in Europe made up 11.8% of total data analytics jobs - up from 11.1% in the same quarter last year. That was followed by North America, which saw a -0.4 year-on-year percentage point change in data analytics roles.

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Fluzone High-Dose Quadrivalent, Flublok Quadrivalent, Fluzone Quadrivalent Vaccines Receive FDA Approval for 2022-2023 Flu Season

Pharmacy Times

The FDA approved a licensure request for Fluzone High-Dose Quadrivalent, Flublok Quadrivalent, and Fluzone Quadrivalent for use in the upcoming 2022-2023 flu season, providing influenza vaccination for adults 65 years of age and older.

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StartUp Health takes a multidisciplinary approach to fight type 1 diabetes

pharmaphorum

David Weingard, chief impact officer of T1D Moonshot and founder of Cecelia Health, tells us how T1D Moonshot aims to break silos and advance type 1 diabetes prevention and treatment options by utilising numerous partners’ expertise. In the US alone, 37.3 million Americans live with diabetes, with 1.6 million having type 1 diabetes (T1D). Still, a scarcity of T1D treatments exists.

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Sema4, Avera Health partner on precision cancer care initiative

Outsourcing Pharma

The health care system and analytics company are joining on the ASAP study, a program that constitutes a five-year commitment to advancing cancer solutions.

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Specialised Therapeutics’ breast cancer drug gets Philippines FDA approval

Pharmaceutical Technology

Specialised Therapeutics’ oral drug, Nerlynx (neratinib) has obtained the Philippines Food and Drug Administration approval to lower the recurrence or mortality risk in early-stage HER2-positive (HER2+) breast cancer patients. The treatment is indicated as extended adjuvant treatment for adults with early-stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy.

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Ofatumumab Shows Long-Term Improvements in Multiple Sclerosis Disease Activity

Pharmacy Times

After 4 years of treatment with ofatumumab, 78.8% of patients with relapsing forms of multiple sclerosis who continuously received ofatumumab achieved NEDA-3 compared to 51.8% of those who switched from teriflunomide to ofatumumab.

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Preventing the next pandemic: Supporting early-stage R&D

pharmaphorum

In the second of a three-part series, Ben Hargreaves looks at the importance of early-stage research into various emerging infectious disease threats and how it saved precious time in the work to develop a working vaccine during the current pandemic. When COVID-19 first emerged, scientists cautioned that developing an effective and safe vaccine could take longer than the commonly estimated figure of a year.

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Optimising Bacillus spores for sporicidal efficacy assessments

European Pharmaceutical Review

Bacterial spores are a significant concern for aseptic pharmaceutical manufacturers due to their ubiquitous nature and intrinsic resistance to environmental stressors such as heat, as well as chemical and radiation inactivating strategies. As much as 10 percent of microbes in a pharmaceutical cleanroom are spore-forming bacteria, with strains such as Bacillus species, able to cause human disease.