Tue.Apr 18, 2023

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In a town plagued by an environmental crisis, a local abortion debate consumes public attention

STAT

BRISTOL, Tenn. — Zoe Poplin cupped her hands around her 17-month-old’s head, as if her palms over his ears could protect him. “I’m worried about him,” she said. She stroked baby Ezra’s back. “Because when they’re little, you know, their little cells are splitting real fast, and he’s growing and all it takes is one misreading, and he could end up with childhood cancer.

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A CMO’s quest to tackle infectious diseases leads him to an eye condition that’s often overlooked

PharmaVoice

How an “international” childhood sent Dr. José Trevejo, Tarsus’s chief medical officer, on a mission to fight infectious diseases.

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FDA says older adults and the immunocompromised may get a spring booster dose of Covid vaccine

STAT

People ages 65 and older and those who are immunocompromised will be allowed to receive an additional dose of Covid-19 vaccine this spring if they wish, the Food and Drug Administration announced Tuesday. In authorizing another dose for people in these demographics, the agency is following in the footsteps of Canada and the United Kingdom, which earlier announced that older adults, adults who live in care facilities, and people who are immunocompromised would have access to an additional booster

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Depression has long been treated chronically — Sage wants to change that

PharmaVoice

Sage Therapeutics is planning a launch of its newest med, and its chief business officer explains how it could upend the way depression has long been treated.

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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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Opinion: Rural hospitals are closing labor and delivery services. Babies’ lives are in jeopardy

STAT

A hospital in Idaho recently announced it will shutter its labor and delivery services due to doctors’ unwillingness to practice medicine in the face of the state’s restrictive and punitive laws surrounding reproductive health care. This comes on the heels of a hospital in rural Washington state closing its labor and delivery services due to concerns over the cost of these services.

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GSK to buy Bellus Health and its chronic cough drug for $2B

BioPharma Dive

The acquisition gives GSK a competitor to a similar drug being developed by Merck for the condition, which the companies estimate affects millions of people in the U.S.

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More Trending

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FDA approves IntelGenx’s Rizafilm for acute migraine treatment

Pharmaceutical Technology

IntelGenx Corp announced that the US Food and Drug Administration (FDA) has approved the company’s Rizafilm VersaFilm new drug application (NDA) for the treatment of acute migraine. The approval was based on successful results from a bioequivalence study comparing Rizafilm to Merck and Co’s Maxalt-MTL and the European reference Maxalt-Lingua. Rizaport and Maxalt are different formulations of Rizatriptan benzoate.

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Multiple sclerosis market to generate sales of $29.8 bn by 2030: GlobalData

Express Pharma

The market for multiple sclerosis (MS) disease-modifying therapies (DMT) is set to experience moderate growth across the seven major markets (7MM*) from $18.9 billion in 2020 to $29.8 billion in 2030 at a compound annual growth rate (CARG) of 4.6 per cent, forecasts GlobalData. GlobalData’s latest report, ‘Multiple Sclerosis: Seven-Market Drug Forecast and Market Analysis to 2030 – Update’ , identified the potential launch of 10 new pipeline products as the main driver of the market’s growth.

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J&J leans on cancer drug sales to maintain first quarter growth

BioPharma Dive

Revenue topped analyst forecasts on strong market performance from the pharma’s multiple myeloma treatments, as well as the last quarter of significant COVID-19 vaccine sales.

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Jubilant Ingrevia commissions new acetic anhydride plant at Bharuch, Gujarat

Express Pharma

Jubilant Ingrevia announced the commissioning of its new Acetic Anhydride plant, at its manufacturing facility in west India at Bharuch, Gujarat. This plant adds around 60,000 MT of capacity, whereby scaling Jubilant Ingrevia’s overall annual Acetic Anhydride capacity to 210,000 MT. This enhanced capacity will also help the company to increase its global presence in various geographies and achieve a leadership position in the global merchant markets.

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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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Macomics reveals pivotal ENIGMAC data

Pharma Times

Drug discovery platform is a tool specifically designed for gene-to-function studies using human macrophages

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Dr Reddy’s ropes in Sonu Sood as brand ambassador for Rebalanz VITORS

Express Pharma

Dr Reddy’s Laboratories announced that it has roped in Sonu Sood as its brand ambassador for Rebalanz VITORS. It has also released a new TV campaign starring him that sends out the message of making an informed choice for an active lifestyle. Launched in 2018, Rebalanz VITORS is a ready-to-serve fruit beverage with essential electrolytes and minerals to help replenish essential salts in the body.

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GSK to acquire BELLUS for £1.6 billion

European Pharmaceutical Review

GSK has agreed to acquire late-stage biopharma BELLUS Health, for a total of £1.6 billion. The proposed acquisition will give GSK access to camlipixant, a highly selective P2X3 antagonist for first-line treatment of adults with refractory chronic cough (RCC). “This proposed acquisition builds on our expertise in respiratory therapies,” commented Luke Miels, Chief Commercial Officer at GSK.

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Pharmacy professionals invited to feed back on National Care Records Service

The Pharmacist

Pharmacy professionals have been invited to give feedback on the National Care Records Service (NCRS), which will replace the Summary Care Record portal (SCRa) from September. In addition to accessing a patient’s Summary Care Record, the new service also allows pharmacy professionals that can already access SCR – that is, pharmacists and pharmacy technicians registered […] The post Pharmacy professionals invited to feed back on National Care Records Service appeared first on The Pharmacist

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Nektar lays off more staff in effort to sustain operations

BioPharma Dive

The decision to cut another 80 or so employees follows a trial setback, a canceled partnership and a failed merger bid. The CFO has also stepped down.

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Regeneron v. Mylan – Update on Aflibercept BPCIA Litigation

Big Molecule Watch

As we previously reported , Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding on an expedited schedule, with a two-week trial scheduled to begin on June 12, 2023, less than a year from Regeneron’s filing of its complaint in August 2022. The Court’s scheduling order , issued in October 2022, required Regeneron to immediately identify six patents for the June trial from among the 24 patents originally listed in Regeneron’s Complaint.

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ICR in research partnership with NeoPhore

Pharma Times

Collaboration will further boost its promising pipeline of cancer treating therapies

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GV’s Cathy Friedman on optimism in biotech and the pitches she’s tired of hearing

BioPharma Dive

The biotech veteran spoke to BioPharma Dive about how platform companies can convince investors of their value, and the buzzwords that make her wary.

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The Best supplements for rheumatoid Arthritis and osteoarthritis

Welltopia Pharmacy

Did you hear about natural supplements that help in joint arthritis like (curcumin&turmerin)?Is this a scientific fact?!Is this a trick?

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Cocktail of modified antibodies provides strong effect against SARS-CoV-2

World Pharma News

Is it possible to improve the antibodies that the body produces to fight SARS-CoV2? In a study led by researchers from Lund University in Sweden, this was investigated by redesigning antibodies and combining them against the virus. The modified antibodies have been tested in human cells and with mice. Many antibodies used to treat covid infection during the pandemic have been so-called neutralizing antibodies that prevent the virus from infecting the cell.

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The Inflation Reduction Act: 10 Predictions About Market Access and Drug Channels

Drug Channels

Like it or not, the Centers for Medicare & Medicaid Services (CMS) is barreling ahead with its implementation of the Inflation Reduction Act of 2022 (IRA). Last Friday was the last day to submit comments on CMS's initial guidance on the drug price negotiation program. The IRA will alter many crucial aspects of the Medicare program and the overall drug channel.

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Leading innovators in HIV peptides for the pharmaceutical industry

Pharmaceutical Technology

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: HIV peptides.

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DEA Designates 4-Piperidone, Used in Illicit Manufacture of Fentanyl, A List I Chemical

FDA Law Blog: Biosimilars

By Larry K. Houck — In addition to regulating drugs of abuse, the federal Controlled Substances Act (“CSA”) controls the manufacture and distribution of chemicals used in the illicit manufacture of controlled substances. As the primary agency enforcing the CSA, the Drug Enforcement Administration (“DEA”) previously designated nine chemicals used in the illicit manufacture of fentanyl or its analogues as List I or List II chemicals.

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FDA approves expanded indication for AbbVie’s chronic migraine treatment

Pharmafile

US-based AbbVie has announced that the FDA has granted approval for the expanded indication of its preventative chronic migraine treatment Qulipta (atogepant). Qulipta is an oral calcitonin gene-related peptide (CGRP) receptor antagonist, and the only one approved to prevent migraine across frequencies, including episodic and chronic. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology and studies have shown elevated levels of CGRP durin

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Interview: How to avoid unnecessary legwork and data scraping with Aerona's modern approach across pharma divisions

Outsourcing Pharma

Aerona Clinical is a medium sized pharmaceutical company, represented not only in the United Kingdom, but in Europe, and with a global reach. The company has been operating in this environment in the pharma industry for 15 to 20 years.

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Gamida Cell’s Omisirge receives FDA approval

Pharmafile

Cell therapy pioneer Gamida Cell has announced FDA approval of its allogeneic cell therapy, Omisirge (omidubicel-onlv), for use in adult patients and paediatric patients over the age of 12. The drug is intended to treat patients with haematologic malignancies planned for treatment with umbilical cord transplants and myeloblative conditioning to reduce the time to neutrophil recovery and the incidence of infection.

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Sterling Pharma Solutions Granted MIA (IMP) License by MHRA for cGMP Antibody-Drug Conjugate Manufacturing at its Facility in Deeside, UK

Pharma Mirror

Dudley, UK, April 18th 2023: Sterling Pharma Solutions, a global contract development and manufacturing organisation, today announced that it has been granted a Manufacturer’s Authorisation for Investigational Medicinal Products from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). The license allows Sterling to manufacture antibody-drug conjugates (ADCs) for clinical use in its current Good Manufacturing Practices (cGMP) compliant manufacturing facility in Deesid

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GSK enters into £1.6bn deal to acquire Bellus Health

Pharmafile

UK-based GSK has announced its plans to acquire Bellus Health, a Canadian late-stage biopharmaceutical company which focuses on treatments for refractory chronic cough (RCC). The acquisition will give GSK access to camlipixant, Bellus’ first-in-class treatment for RCC. Camlipixant is a highly selective P2X3 antagonist currently in phase 3 development, where P2X3 is a validated biological target implicated in cough reflex hypersensitisation.

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Leading innovators in glycoside hydrolase-based drug compositions for the pharmaceutical industry

Pharmaceutical Technology

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Glycoside hydrolase-ba

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New patent for Fennec Pharms drug PEDMARK

Drug Patent Watch

Annual Drug Patent Expirations for PEDMARK Pedmark is a drug marketed by Fennec Pharms Inc and is included in one NDA. It is available from one supplier. There are three… The post New patent for Fennec Pharms drug PEDMARK appeared first on DrugPatentWatch - Make Better Decisions.

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Leading innovators in lipase compositions for the pharmaceutical industry

Pharmaceutical Technology

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Lipase compositions.

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Over-the-Counter Birth Control Pills: FDA Considering HRA Pharma’s Opill

Birth Control Pharmacist

Why Over-the-Counter Birth Control? Oral contraceptives have been around since 1960, and their risks and safety profiles have been well-studied throughout the years. According to the Guttmacher Institute, unplanned pregnancies account for 45% of all pregnancies in the US. Furthermore, nearly one-third of individuals who have tried to obtain a prescription for hormonal contraception report difficulty doing so.

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FDA AdCom supports Entasis’ antibiotic for resistant infections

Pharmaceutical Technology

On 17 April, a US Food and Drug Administration (FDA) Advisory Committee (AdCom) has unanimously voted in favour of the potential approval of Entasis Therapeutics’ sulbactam-durlobactam for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex.

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Moderna and Merck Announce Positive Findings from Personalized Vaccine Study

PharmaTech

Moderna and Merck reported that a combination therapy involving pembrolizumab and an mRNA demonstrated a 44% reduction in recurrence or death in cancer patients compared to non-combination treatments.

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We're a Leader in Procurement BPO and Transformation Services

Pharma and Life Sciences Blog

We're a Leader in Procurement BPO and Transformation Services Vijendra Wed, 04/19/2023 - 00:44 GEP recognized in the ISG Provider Lens™ 2023 Asset type Research Reports Banner Slide Title We're a Leader in Procurement BPO and Transformation Services Mobile Banner Image Top Banner Download Link Read Now

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