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AstraZeneca shares positive results from Imfinzi trial

AstraZeneca has shared positive results from phase 3 trial for imfinzi treating lung cancer

Contents

This issue covers the latest news, and articles on compounded medication and menopause

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Exploring menopause symptoms, treatments and options

New clinical trial aims to find new endometriosis treatment

A new clinical trial is set to begin shortly, which will be a collaboration between the universities of Edinburgh, Aberdeen and Birmingham. The study will assess the efficacy of the drug dichloroacetate in managing pain for patients with endometriosis.

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AstraZeneca signs $63m agreement for gastric cancer treatment

AstraZeneca has announced that it has signed an exclusive licence agreement (ELA) with KYM Biosciences for cmg901, which is an antibody drug conjugate (ADC) intended to treat gastric cancer.

Biotech centre focusing on gene therapies opens in Bristol, UK

A new state-of-the-art facility named the Clinical Biotechnology Centre (CBC) is opening in Bristol, UK. It cost approximately £10m to build, funded by the UK Government.

MHRA’s authority restored following Northern Ireland Brexit deal

The Medicines and Healthcare Products Regulatory Agency (MHRA) has been limited to approving medicines in Great Britain (England, Scotland and Wales) in the wake of Brexit, with the EMA still responsible for Northern Ireland. However, it is looking likely that a new deal with the EU will restore the agency’s authority over the whole of the United Kingdom.

Moda Living and LloydsPharmacy partner to offer residents a prescription service

Moda Living has announced a partnership with LloydsPharmacy to bring residents a ‘health concierge service’ through videogp.

NICE approved BMS’s Opdivo for lung cancer

Bristol Myers Squibb’s (BMS) immunotherapy drug opdivo (nivolumab) has become the first to be cleared for NHS use alongside chemotherapy as a pre-surgery (neoadjuvant) therapy for patients with resectable non-small cell lung cancer (NSCLC).

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AbbVie gains positive CHMP opinion for upadacitinib for the treatment of Crohn’s disease

AbbVie has announced that it has received positive feedback from the EMA's Committee for Medicinal Products for Human Use (CHMP) recommending the approval of upadacitinib (rinvoq) for the treatment of adult patients with moderate to severe crohn’s disease who have had an inadequate response, lost response or were intolerant to conventional therapies or biologic agents.

CSL receives CMA from the European Commission for haemophilia B drug

CSL, a biotech company, has announced that it has received conditional marketing authorisation (CMA) from the European Commission (EC) for its haemophilia b drug hemgenix.

Merck to appeal EU rejection of COVID-19 drug

Life sciences giant Merck & Co has announced that it will appeal the EU's committee for Medicinal Products for Human Use’s (CHMP) decision to not recommend approval for its COVID-19 drug lagevrio.

Eli Lilly caps consumer insulin costs at $35

Eli Lilly & Co has announced that it will cap out-of-pocket insulin costs at $35 per month, following a plea from President Joe Biden for more affordability for diabetes treatments for all Americans.

FDA grants de novo approval to Neuromod’s tinnitus device

The FDA has granted de novo approval to Neuromod’s Lenire device, which includes bluetooth headphones, a handheld controller and the tonguetip intraoral device to treat tinnitus.

FDA sued by US states over abortion pill access

Attorneys general (AGs) from 12 Democrat-led US states have made complaints to the FDA in an attempt to force the body and commissioner Robert Califf to relax restrictions on access to abortion drug mifepristone.

Horizon Therapeutics announces real-world treatment results for dysthyroid optic neuropathy drug

Biopharma company Horizon Therapeutics has announced real-world treatment results for its thyroid eye disease (TED) drug in patients with dysthyroid optic neuropathy (DON) who have not responded to previous treatment.

Mologic’s COVID-19 rapid antigen self-test receives FDA Emergenc y Use Authorization for home use

US subsidiary of Global Access Diagnostics (gadx) ‒ a developer of lateral flow and rapid diagnostic technologies, products and services ‒ Mologic , has announced that its COVID-19 rapid antigen self-test has received FDA emergency use authorization (EUA).

Sun Pharma recalls at least 34,000 bottles of generic drug

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.

Abbott announces positive clinical study data for both TriClip system and MitraClip therapy

Abbott has announced positive data from two separate studies, which looked at its triclip transcatheter edge-to-edge repair (teer) system and its mitraclip therapy for treating leaky valves in people with mitral regurgitation (mr).

Wearable sensor helps detect heart attacks

RCE Technologies has developed a bracelet-like device that can measure levels of troponin-i in the patient’s blood, providing a more efficient way of detecting heart attacks. The device was assessed in a real-world study with results presented at the American College of Cardiology (ACC) annual meeting.

Nasal spray that relieves migraines in minutes approved by FDA

Pfizer is planning to launch a fast-acting nasal spray that can relieve pain from migraines in as little as 15 minutes for some patients. Zavzpret (zavegepant) has been approved by the FDA as the first calcitonin gene-related peptide (cgrp) inhibitor formulated as a nasal spray to treat acute migraines in adults with or without aura.

Funding to increase access to early phase clinical trials given to Yale Cancer Center

Yale Cancer Center has announced it has received collaborative funding aiming to support and increase access to early phase clinical trials for patients at community sites for cancer care in Connecticut, US.

Gilead Sciences wins $175m in ongoing HIV fraud case

Gilead sciences, a research-based biopharmaceutical company, has won again in the lawsuit levelled against clinics, prescribers, medical labs and pharmacies in relation to fraudulent claims for HIV medications.

Moderna to pay $400m to US government over new COVID-19 vaccine licence

Moderna, a leader in the development of COVID-19 vaccines, announced that it has paid the national institute of allergy and infectious diseases (niaid) $400m in a “catch-up payment”, under a new royalty-bearing licence agreement between the organisations.

Medtronic’s extravascular defibrillator receives CE mark

Medtronic has received the CE mark for its extravascular defibrillator. The Aurora EV-ICD MRI SureScan and epsila EV MRI SureScan defibrillation lead treat abnormally fast heart rhythms, which can lead to sudden cardiac arrest.

Moderna chooses Oxfordshire for new UK facility

US biotech firm Moderna has chosen Harwell Science Campus in Oxfordshire for its new UK R&D facility. The campus is already home to more than 70 organisations and sits within the UK’s ‘golden triangle’, an area rich in life sciences facilities, between Oxford, Cambridge and London.

REGENXBIO presents interim phase 2 data from drug developed on NAVXpress platform

REGENXBIO, a clinical-stage biotech company, has announced positive phase 2 data for its drug rxg-314, which was developed by the company’s NAVXpress bioreactor platform process.

Bristol Myers Squibb and Viz.ai sign multi-year partnership for HCM device

Bristol Myers Squibb and Viz.ai, an AI-powered medical imaging company, have signed a deal to use AI to detect and triage patients with suspected hypertrophic cardiomyopathy (hcm).

Elon Musk’s Neuralink rejected by FDA for human trials

The FDA has reportedly rejected a bid by Elon Musk’s Neuralink in which it proposed the initiation of human testing for its brain chip implants. The company has been working on brain implants that allow for a computer-brain interface, which could allegedly restore vision to the blind and help paralysed people to walk again.

Sooma receives FDA Breakthrough Device designation for depression therapy device

Finnish company Sooma medical has received breakthrough device designation by the FDA for its portable, at-home neuromodulation device to treat depression.

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Compounded Medication: What Do We Need To Know?

Rizvan Faruk Batha from Specialist Pharmacy tells Pharmafocus about the history and benefits of compounded medication and why it’s not as common in the UK as the rest of Europe, North America and Australia

Menopause legislation, charities and support

Pharmafocus' Betsy Goodfellow explores the range of legislation, charities and support available for women going through menopause

Menopause and sleep disruption

Betsy Goodfellow from Pharmafocus considers the impact menopause has on sleep and why so many women struggle with disrupted sleeping

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BenevolentAI appoints Marcello Damiani to its board of directors

BenevolentAI has appointed Marcello Damiani to its board of directors. Damiani is expected to act as an independent nonexecutive director of the company.

Deepak Singh appointed as CN Bio’s vice president of Sales and Marketing

CN Bio has announced the appointment of Deepak Singh as vice president of sales and marketing, supporting the company’s next phase of commercial development as it aims to expand international operations, product research and development and sales in key global markets.

Karen Harrison appointed chief operating officer for Avacta’s Therapeutics Division

Avacta has appointed Karen Harrison as chief operating officer of its therapeutics division.

Richard Stedman appointed to CEO of ACG’s Engineering Division

ACG, a leading supplier of integrated manufacturing solutions to the global pharmaceutical and nutraceutical industries, has announced that Richard Stedman will rejoin the company as group chief executive officer of the engineering division.