PHARMA LITERATI

On the first Monday in March, Michel Vounatsos, chief executive of the drug company Biogen, appeared in good spirits. The company's new Alzheimer's drug was showing promise after years of setbacks. Revenues had never been higher. Onstage at an elite health care conference in Boston, Vounatsos touted the drug's "remarkable journey." Asked if the coronavirus that was ravaging China would disrupt supply chains and upend the company's big plans, Vounatsos said no. " So far, so good ," he said.    But even as he spoke, the virus was already silently spreading among Biogen's senior executives, who did not know they had been infected days earlier at the company's annual leadership meeting. Biogen employees, most feeling healthy, boarded planes full of passengers. They drove home to their families. And they carried the virus to at least six states, the District of Columbia and three countries, outstripping the ability of local publi...

The European Medicines Agency (EMA) provides full fee waivers for scientific advice applications from developers of potential therapeutics (to treat the disease) or vaccines (to prevent the disease) against the novel coronavirus disease (COVID-19). Developers of potential therapeutics or vaccines against COVID-19 are invited to contact the Agency as soon as possible with information about their proposed development, by emailing 2019-ncov@ema.europa.eu. In a first round of discussions, EMA can provide preliminary informal comments and feedback on the development. This will then allow the Agency to identify the products which are mature enough to benefit from fast-track scientific advice, to guarantee best use of this tool. In the context of the COVID-19 pandemic, with this fast-track scientific advice, the Agency can give developers prompt guidance and direction on the best methods and study designs to generate robust information on how well a medicine or vaccine works and...

As the cost and use of pharmaceuticals is now on the front page of newspapers and a top priority for employers, government, and individuals, some people think that this is a new phenomenon. However, drug costs have been discussed and analyzed for decades. As you plan for 2020 and beyond, here are some key questions to consider: 1. Who is the customer for pharmaceuticals and pharmacy services? The customer is changing from a physician-centric to a patient-centric world.  2. What are appropriate pharmaceutical pricing strategies? Employers are questioning the value of new drug treatments and their price. As patients pay more of the cost of these expensive therapies, drug companies are trying to develop value-based contracting ties to outcomes to address the cost problem. Drug companies are also launching more “specialty drugs” that are covered under the medical benefit, so these drugs cannot be managed. The current conversation around the future of rebates is inte...

To improve the ultimate health outcomes for patients and enhance their overall experience at all its facilities,  Aster DM Healthcare  is setting up  Aster Innovation and Research Centre  in GCC and India. Over the next three years, the centre will aim to achieve key milestones like the introduction of innovative solutions for home healthcare with a focus on  digital primary care , establishing a rich eco-system of digital health partners from start-ups to academia and starting digital health/ informatics/ medicine as a stream for future healthcare workers. Joining as the Chief of Innovation, Dr Satish Prasad Rath, MD would be spearheading the innovation projects, that will be aiming to leverage the advances in digital health research like AI,  cognitive psychology ,  blockchain , IoT, behavioral economics, etc. and on-board start-ups which can drive innovation. The centre will also work in a collaborative manner focusing on applied rese...

Source: Pharmaprojects; Credit: Informa UK.

Pharmaceutical companies need to adopt technologies such as AI and advanced analytics, to not only improve efficiencies and reduce costs, but also to adapt a more patient centric business models, says a new FICCI-KPMG paper on artificial Intelligence and advanced analytics in pharmaceuticals. Globally, there is pressure to reduce costs and demonstrate greater value, swinging from treatment to prevention and personalised treatments, which is posing a challenge to the overall business model of the pharmaceutical companies. AI and advanced analytics can process large amount of complex, both structured and unstructured data at a rapid pace to generate actionable insights and thereby reduce costs, to improve time to market and gain competitive strength in the market place. While major global companies are investing heavily in this sector, it is only recently that pharmaceutical companies have started to demonstrate significant interest in AI application for various R&D (research a...

We are pleased to share the use of Lecithins & Phospholipids For Pharmaceutical Applications for our readers. The video is created by Ms. Tanvi Gavankar, Technical Marketing Executive at VAV Life Sciences Pvt. Ltd, Mumbai.  https://www.youtube.com/watch?v=XLu2IddlLm4&feature=youtu.be **Disclaimer - The copyright of the video are with the creator of the video. We are sharing the video as it useful for pharmacy students and professionals with prior permission from the creator....

Dive Brief: • Amid intense scrutiny on pharmaceutical innovation and drug value, the industry saw far fewer novel drugs approved by the Food and Drug Administration in 2016 than in years past. • Only 22 new molecular entities (NME) were approved this year, down substantially from the two-decade high of 45 last year. • Adding to that poor showing, a new report published earlier this month put the projected returns from pharma's late-stage drug pipeline at a measly 3.7%. Taken together with the falling NME approvals, the report raises questions about the efficiency and success of pharma R&D. Dive Insight: The report, compiled by the consulting and accounting firm Deloitte , paints a picture of an industry caught between rising R&D costs on one hand and falling average projected peak sales on the other. According to Deloitte, the cost to usher a drug from discovery all the way through launch - an elusive and usually controversial figure - stabilized at a lit...

The Cabinet on Wednesday approved the sale of surplus land of ailing state-owned pharma companies Indian Drugs & Pharmaceuticals Limited ( IDPL ), Rajasthan Drugs & Pharmaceuticals Limited ( RDPL ), and Bengal Chemicals & Pharmaceuticals Limited ( BCPL ) to pay off their existing liabilities. While IDPL and RDPL will be closed down after settling their current liabilities, the Union government will explore the option to undertake a strategic sale of BCPL and Hindustan Antibiotics Limited at a later stage, according to an official statement. “ In this way, the national assets would be utilized in the best national interest. The sale (of land) would be through open competitive bidding to government agencies and the outstanding liabilities will be met from the sale proceeds .” The public sector firms have also been asked to implement a Voluntary Retirement Scheme and Voluntary Separation Scheme for their employees. The remaining part of their land assets wil...

The first phase of prestigious Pharma City project on the outskirts of Hyderabad is moving at a faster pace and is expected to be completed by end of 2018. As part of this, the state government of Telangana has already acquired 5640 acres of land out of required 15,000 acres and had already started building basic infrastructure facilities like roads, drainage and common effluent treatment plants. “ We are planning to build a chain-type Pharma City, which is designed as a self contained facility with residential townships for people working there in addition to a pharmaceutical university and a research centre among other things ,” informed K. Taraka Rama Rao, minister for industries and information technology. Conscious about environmental concerns, the state government of Telangana is encouraging the Pharma City project to be developed as a zero-liquid discharge facility while adequate precautions will be taken to make it environmentally safe and pollution free. “ Pharma ...

Millions of people in the developing world rely directly on cheap, generic pharmaceuticals as their only source of affordable medicine. A majority of these generics are produced in India, often referred to as the “pharmacy for the developing world” because of their unique patent laws. However, recent market intervention from the United States and the European Union threatens India’s ability to produce these drugs, and thus, the availability of medicine in the developing world. Let’s take a look as to why these drugs are overpriced, and what Western intervention on the pharmaceutical market for developing countries means for the future of Big Pharma. Why are drugs so expensive? Because of patents and cost of production. Or at least that is what the drug companies say. For years, drug companies have been using $1 billion as the industry standard for the cost of production of a new medication. A recent Forbes study found that the actual cost of production for every successful dru...

India may have emerged as a key supplier of generic and affordable medicine for the world market, but it has an “overwhelming dependence” on China for the raw material required to produce these drugs, industry association Assocham said. Indian companies depend on China to supply them with the main raw material in drug making — known as Active Pharmaceutical Ingredient (API). The dependence is to the extent of over 65 per cent, an ASSOCHAM-RNCOS joint paper said. Though the government has taken steps like withdrawal of exemption in customs duties, imports worth Rs 13,853 crore in 2015-16 or 65.29 per cent of the total imports of Rs 21,216 crore are not sustainable, the association said. “ This is all the more disconcerting in the face of louder narrative against reducing trade gap with China which is well over USD 51 billion ,” it said. The API is the organ by which active pharmaceutical ingredients are manufactured from raw materials through both chemical and physic...

Ever since the USFDA first announced the $500 million dollar fine against Ranbaxy Laboratories in 2013, there have been a raft of scandals involving the Indian pharmaceutical industry. All of the big names in the industry including Sun, Dr. Reddy’s, Wockhardt, GVK Bio, Alkem have come under scrutiny from foreign drug regulators. These investigations have resulted in a range of regulatory actions against Indian companies by foreign regulators. Instead of taking the cue from its foreign counterparts and increasing regulatory scrutiny, the Drug Controller General of India (DCGI) appears has been on a drive to reduce the regulation governing the Indian pharmaceutical industry in the name of ‘Make in India’. In two public notices over the last month, the DCGI has announced its intention to extend the validity of licences granted to clinical research organisations (CROs) conducting bioequivalence and bioavailability studies and to licences granted for the manufacture, sale and distri...

This election cycle, there are two radically different candidates: the magnanimous tycoon Donald Trump representing the Republicans and the experienced former First Lady, former Senator, and former Secretary of State, Hillary Clinton representing the Democrats. After each party's respective national convention, the candidates released their full political platforms for this race. How do the candidates line up on pharmaceuticals and healthcare? Donald Trump Trump has set his focus on restructuring the so-called "Obamacare" (the Patient Protection and Affordable Care Act), but not in all the ways people assume. While other Republicans talked about repealing Obamacare, Trump wants to focus on reducing the costs of prescription drugs for the American people through allowing drug reimportation and increasing the amount of generics available. Presently, drugs manufactured abroad are not permitted to be offered for sale in the United States. US citizens have bee...