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PBR Staff Writer Published 25 March 2014 US-based Goodwin Biotechnology has entered into an agreement with Aspyrian Therapeutics for the technology transfer, process development, scale-up, and cGMP manufacturing of a new Antibody Drug Conjugate (ADC) for use in Phase I clinical trials.

PBR Staff Writer Published 21 March 2014 Novartis has launched the Lucentis (ranibizumab) pre-filled syringe (PFS) in Germany and plans to introduce the product in other markets throughout 2014. In October 2013, the company has received approval from the European authorities for Lucentis PFS, which is a new way of administering Lucentis that is specifically designed for intraocular injection to enhance patient safety and convenience for the treating clinician.

A pioneering study looking into the possibility of combining existing therapies to slow down cancer growth is showing encouraging early results. Elly Earls reports. A first-of-its-kind medical study at The Care Oncology Clinic on Harley Street, London, has started work on evaluating whether the use of a combination of safe, tolerable, existing, generic therapies could slow down cancer growth and improve survival times in patients for whom other treatments are no longer available or working.

Pharma Process Validation

Digital health interventions (DHIs) are fast emerging as vital tools to promote personal health and provide essential services. DHIs can be accessed through mobile phones, tablets and computers, as well as serve as effective support systems to improve personal health.

Digital health interventions (DHIs) are fast emerging as vital tools to promote personal health and provide essential services. DHIs can be accessed through mobile phones, tablets and computers, as well as serve as effective support systems to improve personal health.

Here's the timeline of how the Coronavirus outbreak evolved from Wuhan city in China and spreading its tentacles across the world.

China is grappling with an outbreak of infections from a new coronavirus that began in December.

Confirmed Covid-19 cases are rising in India, with 30 cases reported so far, a sharp rise from the five cases until 2 March, with the Ghaziabad man in the state of Uttar Pradesh testing positive.

India is witnessing a rise in confirmed Covid-19 cases. Credit: CDC on Unsplash Visit our Covid-19 microsite for the latest coronavirus news, analysis and updates

the "Global Lung Cancer Drugs Market" will grow at a CAGR of 13.6% during the forecast period. The market has witnessed steady growth in the past few years with the introduction of novel products, which have augmented the acceptance of immunotherapy drugs in the market. The market is fueled by upsurge in the incidence of lung cancer cases across the globe - owing to increasing diagnosis rate and mainly due to increasing tobacco consumption, increase in the lung cancer treatment rates, increasing rate of effective drug approvals as first-line therapies, strategic deals to develop new products, increasing R&D spending, and rapid industrialization leading to increased pollution. The report provides complete details about the sub-segments of the lung cancer drugs market. Through this report, the key stakeholders can know about the major trends, drivers, investments, vertical player's initiatives, and government initiatives towards the disease management in the upcoming years along with details of the existing pureplay companies and new players entering the market.

The global market for chronic kidney disease drugs is expected to witness single-digit growth during 2019-2025. The drug pipeline of chronic kidney disease looks promising with novel therapeutic approaches, such as cell therapy, likely to enhance the market growth opportunities. However, the competition from biosimilars and complex drug development processes are impeding the market growth. Over the period, extensive research is being done to fill the unmet needs' gap. The advances in the arena of regenerative treatment have come up with budding advancement of cell therapies that help regeneration and repairing of the kidneys. Cell therapy is proficient of refining the fundamental functioning capability of the kidney. Uncontrolled high blood pressure and diabetes are the leading causes of kidney failure globally.

The full version of the Community Pharmacy Assurance Framework (CPAF) questionnaire is now available for selected pharmacies to complete. This follows a screening questionnaire in July, which all community pharmacies in England were asked to complete as part of the CPAF process. Pharmacies may be selected for the full, comprehensive CPAF questionnaire if, for example, they did not complete a screening questionnaire or if there are concerns about the pharmacy relating to patient safety. Some pharmacies may also be selected to validate their screening questionnaire answers. The NHS Business Services Authority (NHSBSA) said selected pharmacies have been contacted. It's mandatory to complete the survey which can be used as a training tool and for continuous monitoring of compliance against the community pharmacy contract.

The Equality Act (which replaced the Disability Discrimination Act in 2010) is often cited as a reason for supplying medicines in a compliance aid. This is a complex piece of legislation, but, in essence, provides a statutory duty on businesses to make "reasonable adjustments" in relation to the service that they provide to take into account any relevant disability of a service-users. This statutory obligation might include the provision of a compliance aid where a patient would be at a "substantial disadvantage" without. However, the need to provide medicines in a compliance aid under the Equality Act needs careful consideration and is a balancing exercise. The NHS Terms of Service for community pharmacies in England state that medicines should be provided in original packs save in certain circumstances, which include because of patient needs.

After engaging with contractors and stakeholders of NHS Community Pharmacy, the pharmacy review steering group (RSG) is planning to put proposals to contractors' vote before Easter 2022. The group, made up of representatives from the Association of Independent Multiple Pharmacies, Company Chemists' Association and independent community pharmacy, was formed in late 2020 to explore the future of community pharmacy network support. After engagement with the sector, the RSG has defined the roles of the local and national representative bodies, considered the contractor decision-making process, and worked through analysis and suggestions on local representation. It is now focusing on national representation and support.

The British scientist who led the research underpinning AstraZeneca's coronavirus vaccine said at the weekend that a new jab could be developed against the emerging Omicron variant "very rapidly" if needed. Professor Andrew Pollard, director of the Oxford Vaccine Group, also said existing vaccines should work against the new strain, but that would only become apparent after more research in the coming weeks. "It's extremely unlikely that a reboot of a pandemic in a vaccinated population like we saw last year (with the Delta variant) is going to happen," he told BBC radio. But if required, "The processes of how one goes about developing a new vaccine are increasingly well-oiled, so if it's needed that is something that could be moved very rapidly." In a statement, AstraZeneca said it had "developed, in close collaboration with Oxford University, a vaccine platform that enables us to respond quickly to new variants that may emerge".

Hypovase (prazosin) 500 microgram tablets, manufactured by drug major Pfizer, will remain out of stock until mid-January 2022 due to a manufacturing issue. The Department of Health and Social Care (DHSC) and NHS England and Improvement (NHSE&I) have issued a supply disruption alert for the medicine that is used to treat heart-related troubles. Pfizer, the sole supplier of prazosin 500mg tablets in the UK, is out of stock from late November 2021, and had discontinued the Hypovase® (prazosin) 1mg tablets in May 2021. Advice for healthcare professionals In the given situation, prescribers need to review all affected patients to discuss management plans. Meanwhile, alternative medicine alpha blockers remain available to support an uplift in demand.

Advanz Pharma, alongside London-based private equity firms Cinven and HgCapital, is collectively confronted with an £84 million penalty for inflating the price of the thyroid drug by over 1,000 per cent, soaring from £20 to £248 per package over an eight-year period. The Competition Appeal Tribunal endorsed 'all key aspects' of the Competition and Markets Authority's verdict on the companies' culpability in the case, the CMA has said. Advanz stood as the sole supplier of liothyronine tablets, essential for treating thyroid hormone deficiency, with the cost of a packet of these tablets surging over 12-fold between 2009 and 2017. Although Advanz Pharma currently possesses ownership of the company, its former owners, PE firms Cinven and HgCapital, also bear responsibility for the imposed fine, the CMA said. "NHS annual spending on the tablets in 2006, the year before the implementation of the strategy, was £600,000, but by 2009 had increased to more than £2.3 million and jumped to more than £30 million by 2016," Britain's competition watchdog said.

The government has launched a consultation into radically changing the Statutory Scheme for branded medicines (known as the Statutory Scheme). The consultation comes as delicate negotiations for replacing the alternative Voluntary Scheme are underway, potentially undermining these talks, while also further damaging industry confidence in the UK as a viable place to research, launch and supply medicine. The government proposals seek to hold average revenue clawback rates under the Statutory Scheme at historic highs of between 21-27%, compared to the pre-pandemic averages of 9.4% for the Statutory Scheme (2019-2021), and 6.88% for the Voluntary Scheme (2014-2021). The accompanying cost-benefit analysis ignores any negative impact this may have on medicine supply and wrongly claims it will boost investment. The consultation comes on the heels of government data last week showing UK life sciences foreign direct investment (FDI) fell by 47% between 2021 and 2022, down by £900m year on year. This large fall in investment coincided with a rise in the main UK clawback rate under the Voluntary Scheme from 5% to 15%, and led to the UK falling from 2nd to 9th out of 18 comparator countries for life sciences FDI in 2022. The Voluntary Scheme clawback rate now sits at a record 26.5% in 2023.

The National Pharmacy Association (NPA) is calling on NHS England and its member to pause and reflect before further implementing the pharmacy contraception service. NPA board met on Tuesday (25 April) to discuss the Pharmacy Contraception Service and the board decided that - with the community pharmacy sector at breaking point - it cannot support the immediate roll out of this service. The association believes that with no new funding for the service, and all existing funds in effect already allocated to other pharmacy activity, any payments to the sector for delivery of the oral contraception service will ultimately be clawed back by NHS England. Tweeting after the meeting yesterday, the NPA said: "We can't tell pharmacy owners what they can and can't do. But we can tell them the facts; fact number one is that with no new funding currently available everyone will be a loser from the implementation of this service on the current terms." NPA Vice-Chair Jay Badenhorst added: "We cannot be expected to take on more and more services without the increase in funding necessary to deliver them effectively. Meanwhile, taking on additional work when current workload already exceeds capacity risks impacting negatively on the overall quality of care people experience in pharmacies. We still believe this could, in future, be a great new pharmacy service, but not without the extra funding necessary to deliver it safely and effectively. We want to offer women this extra support, but if it's worth doing it's worth doing properly."

Chair of the Health and Social Care Committee Steve Brine MP has called on community pharmacy contractors to join a newly launched a parliamentary 'call for evidence' which will look into 'prevention' as a key to the future of the NHS. A former pharmacy minister and keen supporter of the sector, Mr Brine has called on all community pharmacists to "make their contribution count" by taking part in a major inquiry which will remain open for submission until Wednesday 8 February 2023 and will also involve general practitioners, nurses and other health professionals. Community pharmacists can submit their proposals written under 750 words, outlining what they think are the issues around prevention the parliamentary body should explore, why these issues deserve the Commons Select Committee's attention, and how government policy could be developed or improved to address them. The submissions will then be used to help the committee decide where it should focus its attention in the later stages of the inquiry on prevention, which is a vital part of the NHS Long Term Plan.

Jeremy Meader has resigned as managing director of Numark after five years on the job, and having lead the wider PHOENIX group's sales and marketing teams for about eight years. A press release issued on Wednesday (February 1) said Mr Meader "has decided to leave the business to pursue his career outside of the PHOENIX group", the owner of Numark. It said: "PHOENIX thanks Jeremy for his commitment and dedication over the years and wishes him all the best for his professional and private future." Previous to joining PHOENIX, Mr Meader was head of sales at Alliance Healthcare, a role he took up in 2012 after serving GSK's Consumer Healthcare division for over 13 years in various capacity.