The transition of Class A and Class B medical device makers to the licensing regime by October 1 seems to be an uphill task with several small and medium manufacturers saying they are still awaiting the audit from the government authorities.
The US drug regulator has stepped up its inspection activity in India, and plans to have more surprise or ‘short notice’ inspections, ending the two-year reprieve from ‘warning letters’ and other regulatory measures that Indian drug makers have enjoyed since the onset of the Covid-19 pandemic.
“In terms of (inspection) activity (in India) we are getting closer to pre-pandemic levels,” Sarah McMullen, country director – India at US Food and Drug Administration (USFDA) told ET, at the sidelines of a recent industry event in Mumbai.
McMullen said that the US regulator has resumed surprise inspections in India.
India has the largest number of USFDA-registered drug manufacturing facilities outside of the US. The US accounted for 29% of the total pharma exports of India woth $24.62 billion in FY22. On an average during the pre-pandemic period, India used to see about 200 inspections annually. This number dropped to 80 in 2020, and to just 5 in 2021 due to Covid related disruptions.
This resulted in official action indications (OAIs) and warning letters falling significantly. In 2020, Indian companies received 25 warning letters. This number dropped to 2 in 2021 and stands at 3 far in 2022.
The OAIs, which ranged anywhere from 40-50 a year in India , too fell steeply in the pandemic period. According to a Motilal Oswalreport, Indian manufacturing sites have received 60 OAI citations over Sep’19-Sep’22.
The issue of both warning letters and OAI results in lack of approval for sale of new generic drugs to the US from the concerned plant, often resulting in a fall in the stock price of the impacted company. Postponed inspections also means delay of new product approvals hurting the US business.
USFDA had to postpone foreign inspections or prioritise them based on mission critical status for much of the last two years due to Covid pandemic. With the pandemic receding, the US agency plans to have hundreds of unannounced or short notice inspections.
A $14 million research project is getting underway in the US to see whether cancer and other diseases can be diagnosed by picking up subtle changes in a person’s voice patterns.
The National Institutes of Health (NIH)-funded project is being run by researchers at the University of South Florida in collaboration with Weill Cornell Medicine in New York City, 10 other institutions in the US and Canada, and with the help of French/US artificial intelligence specialist Owkin.
Called Voice as a Biomarker for Health, the programme is one of several receiving NIH support under the agency’s just-announced Bridge2AI initiative, which has set aside $130 million in funding to accelerate the use of AI technologies in biomedical settings.
It aims to develop an extensive database of human voices, both healthy and sick, that can be used to train AI algorithms to detect changes that could be a sign of cancer, neurological and psychiatric disorders like Alzheimer’s or depression, respiratory illnesses such as pneumonia, and voice/speech disorders, including language delay and autism.
There are already a number of examples of projects that have used patient sounds as a biomarker to detect disease including, for example, recordings of coughing to screen people for COVID-19 infection.
Vocal patterns are also starting to attract attention as potential diagnostic tools for conditions, including post-traumatic stress disorder (PTSD), depression, and stress.
“Although preliminary work with voice data has been promising, limitations to integrating voice as a biomarker in clinical practice have been linked to small datasets, ethical concerns around data ownership and privacy, [and] bias and lack of diversity of the data,” say the partners.
“To solve these, the Voice as a Biomarker of Health project is creating a large, high-quality, multi-institutional and diverse voice database that is linked to identity-protected/unidentifiable biomarkers from other data, such as demographics, medical imaging, and genomics,” they add.
The NIH-backed voice project hopes to develop AIs that can be used to “empower doctors with a low-cost diagnostic tool to be used alongside other clinical methods.” It will be backed by $3.8 million in its first year, with the remainder of the $14 million subject to NIH getting budget approvals for the following three years.
“Vocal biomarkers are set to play an increasingly important role in healthcare,” commented Thomas Clozel, co-founder and chief executive of Owkin.
“We are excited to be using federated learning, our privacy-preserving AI framework, to connect the medical world together in the pursuit of improving outcomes for patients,” he added.
Other projects being funded by the Bridge2AI programme are looking at generating standards for biomedical AI, and using machine learning to build a genomic “translator”, based on maps of cell architecture.
Sanofi and AstraZeneca are closing in on EU approval of nirsevimab, their long-acting antibody for the protection of newborns and infants from respiratory syncytial virus (RSV) infections.
The EMA’s human medicines committee – the CHMP – has recommended approval of a single dose of the antibody, given to prevent lower respiratory tract infections caused by RSV, under the Beyfortus brand name.
If approved, Beyfortus would become the first and only single-dose, passive immunisation for a broad infant population, including those born healthy, at term or preterm, or with specific health conditions, said AZ and Sanofi in a joint statement.
AZ’s Synagis (palivizumab) is currently the only approved drug in Europe to provide passive prophylaxis against RSV, but has to be given monthly, whereas nirsevimab can provide protection throughout the several months that comprise the RSV season. In the US, Synagis is sold by Sobi.
The former blockbuster – first approved back in 1998 – is still making solid sales despite losing patent protection, with AZ booking $410 million from the drug last year, but are expected to drop sharply once Beyfortus and vaccines for RSV prevention reach the market.
Pfizer is currently leading the race to bring an RSV vaccine to market for use by expectant mothers, which would transfer protection to newborns and infants, with phase 3 results due next year.
Its closest rival GSK suffered a setback when it was forced to abandon phase 3 trials of its candidate on safety grounds earlier this year. Both vaccines are also being tested in older adults.
Despite the RSV vaccine threat, analysts at GlobalData have predicted that nirsevimabcould reach $3 billion in annual revenue by 2030, assuming a launch next year.
In part, that is because of the scale of the public health crisis caused by RSV. Worldwide, RSV infections lead to more than three million hospitalisations and almost 60,000 deaths in children under five years of age every year, with around half of fatalities in infants less than six months.
“Today’s positive CHMP opinion is one of the most significant public health achievements in RSV in decades and has the potential to alleviate the enormous physical and emotional burden that RSV can place on families and healthcare systems,” said Jean-François Toussaint, Sanofi’s head of vaccines R&D.
“With this endorsement, we are one step closer to achieving our goal of protecting all infants against RSV with a single dose.”
Sanofi bought into the nirsevimab programme in 2017, paying $645 million for marketing rights to the antibody, with AZ retaining the responsibility for developing and manufacturing it. Sobi also has an interest in the new drug as part of its 2019 agreement with AZ over Synagis.
Evusheld also backed for COVID-19
Meanwhile, there was further good news for SAZ from the CHMP today after it recommended approval of Evusheld (tixagevimab and cilgavimab) for the treatment of people aged 12 and over with COVID‑19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease.
The panel gave the positive opinion on Evusheld on the strength of the TACKLE trial, which showed that a single intramuscular dose of Evusheld provided clinically and statistically significant protection against progression to severe COVID-19 or death from any cause compared to placebo.
Evusheld is already approved in the EU for pre-exposure prophylaxis (prevention) of COVID-19, providing an option for patients who do not respond well to coronavirus vaccines, such as those with compromised immune systems.
ObvioGo incorporates real-world data, AI, digital instruments, and integration with clinical systems through APIs and interfaces.
ObvioHealth has introduced a next-generation decentralised clinical trial (DCT) platform and mobile application called ‘ObvioGo’ to provide robust therapeutic efficacy and safety evidence.
The flexible tech stack of ObvioGo is designed to collect and merge more precise multi-source data.
This approach delivers an integrated platform that enables clinical science teams to produce robust treatment evidence.
It has five modules that are interoperable.
One module of the system, Study Design, is a completely configurable technology developed for addressing the shortfalls in existing trial design.
This facilitates sponsors in previewing, testing, and optimising in the initial protocol development stages, depending on what participants and trial groups will see and experience throughout the study.
The Outcomes Capture and Assessment module comprises AI-powered technologies and standard eCOA and RWD interfaces (labs, EHR, imaging) that aid in collecting more precise data from clinicians, caregivers, and subjects.
Mobile Application, an intuitive user interface of the system, provides wide-ranging insight into the study subjects’ digital behaviours.
As against various other DCT platforms, ObvioGo’s Study Management module aids in carrying out vital human interactions that are key to successful trials.
The platform allows both virtual study and conventional site-based teams of the company to interact with subjects directly and provide customised support.
Trial teams could progress to analytical review swiftly using the data management and biostatistics expertise of ObvioGo. This module enables auto-edit checks, automatic data cleaning, and resolving queries.
ObvioHealth CEO Ivan Jarry said: “This is the culmination of years of hard work, developing a best-in-class DCT platform and ecosystem based on insights gained from the delivery of more than 50 fully virtual and hybrid trials in 28 countries.
“ObvioGo is a powerful evidence-generation engine, and this technology, combined with our deep clinical expertise, will propel the industry forward, positioning ObvioHealth as the global leader in decentralised trials.”
In June this year, the company entered a licencing agreement with Dedalus Group to gain access to the latter’s data mining technology.
Researchers have found that an alcohol support group, such as Alcoholics Anonymous, when combined with other treatments is much more effective in getting the alcoholic to stay sober. Folks afflicted with rheumatoid arthritis normally have discomfort caused by inflammation and typically benefit from aspirin or ibuprofen, the best know of which are Motrin and Advil. You probably have acid reflux, if you find after eating, burping, vomiting, sore throat, sour taste in the mouth area and/or a chronic cough you’ve chest pain along with discomfort.
The University of Oxford said on Wednesday it was testing anti-parasitic drug ivermectin as a possible treatment for COVID-19, as part of a British government-backed study that aims to aid recoveries in non-hospital settings.
That means the body’s immune system attacks its own healthy cells and tissues. Currently, it is sorted under autoimmune diseases, i.e. those diseases where the immune system attacks healthy cells in your body by mistake, in this case degrading the articular cartilage. Rheumatoid arthritis is progressive and disabling, and can affect the appearance and the function of the hands and other parts of the body through injury to joints and soft tissue structures.
Immunosuppressive medications help to dampen down the abnormal response of the immune system and are used for treating people with more severe disease, such as when there is damage to internal organs.
Fortunately for most people, the acute pain resolves within days or weeks although in some it may reoccur or become chronic. Approximately two-thirds of the population will suffer from neck pain at some time in their life with high prevalence in the middle ages. Reduced neck movement along with localized areas of muscle tenderness known as trigger points are commonly observed along with pain. There are certain points involved just because from the dangerous virus, and there is no long term way to fix eradicate the coronavirus.
In more serious cases, malaria is treated through an intravenous drip in hospital. This treatment aids in reducing the symptoms of malaria naturally that cause discomfort to most people. To prevent this your doctor will be able to create a treatment plan for your individual needs to stop the infection from returning. The type of parasite you were infected with will also influence whether the infection could come back in the future.
Undeniably, grapefruit is among effective and natural treatments for curing malaria. In high risk malaria zones it is important to take antimalarials, also known as malaria tablets. These following ingredients make effective home remedies to help you treat the malaria disease at home. Your doctor may end up giving you a combination of antimalarials, in the form of tablets or capsules. Taking these tablets correctly for the prescribed period will reduce your risk of malaria by about 90%. This means you should still practise mosquito bite prevention. Antimalarials are the go-to treatment for malaria, however if you were taking malaria tablets when you contracted the disease you will need to be treated with a different tablet.
It is an herbal plant which is known greatly effective in treating the malaria disease. Thanks to containing with natural quinine – like substance that is extracted from boiling a little amount of grapefruit and straining the pulp, it is significantly potential for treating malaria naturally and should be consumed on a daily basis. Lime and lemon together work great at treating he malaria well. It is also great at combating the parasites. Fenugreek seeds are well known for boosting up the immunity level, so adding them to your food is not only great for your health but also prevents you from catching malaria at the first place.
A tumor-like tissue (pannus), which is ultimately responsible for the destruction of the functional structures of the joints over time, forms on the synovium. The disease often manifests itself in small joints, such as those of the hands or the finger joints located closest to the hand.
For this test, a small fluid sample is taken from a swollen joint. X-ray. This test uses a small amount of radiation to create images of internal tissues, bones, and organs onto film. Your HCP may stop your RINVOQ treatment for a period of time if needed because of changes in these blood test results.
The different therapeutics work in different ways, therefore a combination of the available medications is used for treatments nowadays. Each therapy is always a combination of individual approaches, which include a change in lifestyle, any necessary surgeries, the regular medical monitoring with inspections and, most importantly, the medical treatment. Depending on your particular symptoms, and how much pain and inflammation you have, you may take one medication or a combination of different medications. If your pain continues, or if non-surgical treatment doesn’t help, we may suggest surgery to you.
Bayer has won a key FDA approval to extend the use of its prostate cancer therapy Nubeqa, as it tries to claim market share from rival drugs and fulfil its aim of building the drug into a €3 billion ($3.1 billion) blockbuster.
The US regulator has approved Nubeqa (darolutamide) in combination with docetaxel chemotherapy for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC), adding to its earlier indication in non-metastatic castration-resistant prostate cancer (nmCRPC).
The new use in more advanced prostate cancer patients puts the oral androgen receptor inhibitor (ARI) in direct contention with other drugs in the class, notably Pfizer/Astellas Xtandi (enzalutamide) and Johnson & Johnson’s Erleada (apalutamide).
Bayer and its development partner for Nubeqa – Finland’s Orion Pharma – reckon that their drug may have a safety advantage that will help it wrest market share from Xtandi and Erleada, although the incumbents are well-entrenched and widely prescribed by doctors.
The latest approval is based on the ARASENS trial, which showed that adding the drug to standard androgen deprivation therapy (ADT) and docetaxel chemo led to a statistically significant improvement in overall survival (OS) compared to ADT plus docetaxel and placebo.
The risk of death was significantly lower – by around 33% – in the Nubeqa group compared to the placebo group, according to the results, which were published in the New England Journal of Medicine in February.
Around 95% of prostate cancers are localised at diagnosis and treated with surgery or radiotherapy, but tend to relapse. When this happens, the first line of drug treatment for hormone-sensitive tumours is ADT, with chemotherapy layered on top if needed.
Most men with mHSPC will eventually progress to CRPC, which has poor survival prospects. Prostate cancer remains the second leading cancer-related cause of death among men in the US, with up to one-third of patients developing metastatic disease.
Nubeqa is a key new therapy for Bayer as it copes with declining sales of its aging blockbuster anticoagulant Xarelto (rivaroxaban), mainly due to pricing pressures outside the US market and particularly in China.
The drugmaker is anticipating a return to growth for Xarelto in the coming months, but the drug is in the last few years of patent life, along with Bayer’s ophthalmology blockbuster Eylea (aflibercept).
When it comes to future revenue drivers, Nubeqa is pretty much at the top of Bayer’s list along with new chronic kidney disease therapy Kerendia (finerenone) and late-stage clinical candidate elinzanetant for menopausal symptoms.
Last week, Bayer reported sales of Nubeqa doubled in the second quarter of this year to €105 million. Its lofty expectations of €3 billion in peak sales will rely on additional approvals, including for adjuvant (post-surgery) use of Nubeqa in localised prostate cancer with a high risk of recurrence.
The Inflation Reduction Act of 2022, a sweeping measure that now looks likely to be passed through budget reconciliation by Senate Democrats in the US, contains measures intended to greatly reduce US prescription drug prices — but the pharma lobby has reacted strongly against the bill, warning that it will lead to fewer innovative drugs being created, especially for cancer.
Startling news broke Thursday and today that Democrats had convinced Senators Joe Manchin (D-West Virginia) and Krysten Sinema (D-Arizona) to back the Inflation Reduction Act, a multifaceted budget bill that is being noted for its historic scope with regards to combatting climate change. Using a special process called budget reconciliation, the bill can be passed with just 50 votes plus a tiebreaker vote by Vice President Kamala Harris, which means Republican cooperation is not required.
In addition to the climate provisions, however, the bill has a significant effect on prescription drug prices, and according to reports neither Manchin nor Sinema is objecting to these provisions, which are similar but not identical to the ones in the Build Back Better plan which previously passed in the House of Representatives.
Chief among these provisions is that the bill will allow, and indeed require, Medicare, the US’s government-run insurance program for older Americans, to negotiate drug prices with pharmaceutical companies in some cases, something it historically has not been allowed to do. Additionally, the bill would require drug companies to pay rebates if drug prices rise faster than inflation, add a $2,000 cap on Medicare Part D out-of-pocket spending and other Part D benefit design changes, expand income eligibility for Medicare’s low-income subsidy program, improve access to adult vaccines, and repeal a Trump administration drug rebate rule which eliminated rebates negotiated between drug manufacturers and pharmacy benefit managers (PBMs) or health plan sponsors in Medicare Part D.
The non-partisan Congressional Budget Office estimates that the bill will save Medicare $287 billion over the next 10 years, savings that would be passed along to Medicare beneficiaries.
The Pharmaceutical Research and Manufacturers of America (PhRMA) was quick to denounce the bill, sending a letter to all 100 senators which argues in strong terms that the bill will hurt pharmaceutical innovation.
“Proponents are driving the bill under the guise that it will allow Medicare to ‘negotiate’ with biopharmaceutical companies. What the bill actually does is give manufacturers non-negotiable ultimatums – accept whatever price the Secretary of Health and Human Services sets, pay a massive excise tax of as much as 95% of a medicine’s sales or remove all of your products from Medicare and Medicaid,” states the letter, which was signed by representatives from every major US pharma company. “That’s not negotiation, it’s government price setting. We know from experience what happens when governments set the price of medicines: Breakthrough cures start slipping away. In countries with government price controls, patients have access to just half of medicines launched globally since 2012, compared to 85% in the United States.”
The CBO did agree that the bill will negatively impact pharmaceutical innovation, but to a much smaller extent than PhRMA argues. They estimate that the bill would prevent the launch of about 15 drugs over the next 30 years, out of 1,300 expected to come to market in that period. Notably, the bill limits Medicare negotiation to drugs that have been in the market for more than nine years, which proponents argue is plenty of time for drug companies to turn a profit and recoup research and development investments.
Moreover, research by the Kaiser Family Foundation shows that Americans of both parties overwhelmingly support allowing Medicare to negotiate prescription drug prices.
The Technology Development Board (TDB) under the Department of Science and Technology will start extending funds for agricultural field trials and clinical trials for new technologies, according to Rajesh Kumar Pathak, Secretary of TDB.
At a meeting on “Financial Assistance from GoI for Technology Development” here on Saturday, he said its board had decided that it would give funding for agricultural field trials and clinical trials of technologies developed by any organisation or industry. A committee had been formed to decide on the modalities for the funding.
Further, the TDB would enhance capex support start-ups. It would extend upto 70% of the capital expenditure (capex) for start-ups that wanted to commercialise an innovation. While 50% of the capex would be given as loan at low interest rate, another 20% would be given as convertible equity. So far, the TDB supported start-ups that wanted to commercialise new technologies with 50% of the capex.
In a move to promote domestic production, the Ministry of Health and Department of Science and Technology had formed a task force that would recommend a set of chemicals that India would manufacture. These chemicals were currently imported. The committee had met a few times and would come out with the list soon, he said.
On the new Science Technology and Innovation policy, he said the government was likely to come out with it soon.
The collaboration will focus on advancing multiple existing and additional next-generation cell therapies against targets in multiple myeloma, B-cell lymphomas and other hematologic indications
Poseida Therapeutics and Roche have entered into a strategic collaboration and license agreement to develop allogeneic CAR-T therapies for hematologic malignancies.
The collaboration will leverage Poseida’s novel approach to cell therapy and Roche’s expertise in developing and marketing therapies.
It will focus on advancing multiple existing and additional next-generation cell therapies against targets in multiple myeloma, B-cell lymphomas and other hematologic indications.
Under the agreement, Poseida is expected to receive an upfront of $110m and along with up to $110m in near-term milestones and other payments in the next several years.
The company is also eligible to receive potential research, development, launch, and net sales milestone payments of up to $6bn, along with tiered royalties on net sales.
Poseida chief executive officer Mark Gergen said: “We are excited to partner and collaborate with Roche, one of the world’s largest biotechnology companies, which has a successful track record in the discovery, development and commercialization of innovative medicines.
“Roche is an ideal strategic partner for Poseida with its industry-leading R&D capabilities in oncology, complementary technologies and expertise, and global regulatory and commercial capabilities.
“Working together, we look forward to advancing novel allogeneic cell therapies based upon Poseida’s technologies for patients battling cancer.”
Roche will receive either exclusive rights or options to develop and commercialise a few allogeneic CAR-T programs in Poseida’s portfolio, with an IND expected in 2023.
The programs include P-BCMA-ALLO, an allogeneic CAR-T therapy for multiple myeloma and P-CD19CD20-ALLO1, a similar therapy that targets B-cell malignancies.
In addition, the two companies will also collaborate in a research program to create and develop new features and improvements for allogeneic CAR-T therapies.
Poseida will conduct the Phase 1 studies and manufacture clinical materials before the programs are transferred to Roche for further development and distribution.
Roche will be wholly responsible for the late-stage clinical development and global distribution of all the products emerging from the collaboration.
Roche pharma partnering global head James Sabry said: “We are excited to partner with Poseida to further explore the potential of allogeneic cell therapies to transform cancer care by developing off-the-shelf products that can address high unmet medical needs for a broad patient population.
“Poseida’s differentiated platform technologies complement our ongoing internal efforts and partnerships to discover and develop cell therapies as a next generation of medicines for patients.”
