Drug Development Costs See Steep Increase, But Not Enough to Justify Exorbitant Launch Prices
The cost of developing a new drug has risen by 15% to $2.3 billion, according to a report from the consulting firm Deloitte. This steep figure was paired with data showing that return on investments faced an 82% decline in the past year. However, a study published in the British Medical Journal, shows that operating costs contribute more to the increased development cost than research. Moreover, the paper argues that rising drug prices far outstrip any cost increases for biopharma companies.
The FDA Omnibus Reform Act: 8 Points to Remember
The Food and Drug Omnibus Reform Act of 2022 (FDORA) was signed into law last year, granting more power to the US Food and Drug Administration (FDA) to perform inspections at home and abroad. Learn more about the bill and 8 points to note in a recent Pharmaceutical Online article by professionals at Greenleaf Health. The first takeaway is that the bill gives many new inspection tools to the agency.
Sanofi and Sobi Score US Approval for Weekly Hemophilia A Therapeutic
Altuviiio, Sanofi and Sobi’s therapeutic for the blood disease hemophilia A, has just received regulator approval by the US Food and Drug Administration (FDA). The drug stands out in its class due to its dosage regimen; the therapy is delivered once a week versus every couple days with the current standard of care.
FDA Grants Breakthrough Status for Moderna and Merck’s Vaccine Combo Therapy for Skin Cancer
Moderna and Merck have secured a win with the US Food and Drug Administration (FDA) granting breakthrough therapy designation to the companies’ experimental therapy for skin cancer. The treatment combines a new mRNA vaccine with Merck’s existing drug Keytruda to help the immune system fight melanoma.
Senate Commerce Committee Holds PBM Hearing
The pharmacy benefit manager (PBM) industry is under the magnifying glass again, this time by the US Senate Commerce Committee. During the hearing, senators brought up anti-competitive actions taken by major players, as well as other practices that hurt the bottom line for pharmacies and patients alike.
The Far-Reaching Implications of the Potential Abortion Pill Ban
A court case that will determine the fate of nationwide access to the a pill used to induce abortions and treating miscarriage may trigger a sea change in the pharmaceutical industry in the US. If the far right-wing judge presiding over the case, a Donald Trump appointee, rules in favor of rescinding the approval of mifepristone, it will set a precedent that court cases can overrule drug approvals by the Food and Drug Administration (FDA).
US Senators Call for Expansion of Medicare Coverage for Amyloid Alzheimer’s Treatments
Following the controversial approval of the Alzheimer’s drug Aduhelm, the US Centers for Medicare and Medicaid Services (CMS) agreed to only pay for drugs in its class, amyloid-targeted therapies, when used in patients enrolled in clinical trials. A group of Senators have penned a letter to Xavier Becerra, Secretary of the Department of Health and Human Services (DHS) and the CMS Administrator Chiquita Brooks-Lasure.
Eli Lilly Catches Up with Mounjaro Shortage
Eli Lilly announced it caught up on backorders for its obesity drug Mounjaro, drawing the end near for a shortage that’s persisted since last December. Some patients may still have to wait for the drug, but delays will likely drop to one to two days. The drug is still on the US Food and Drug Administration’s drug shortage supply list, which may change in the coming days.
Pharma Preps for Major Exclusivity Losses
As biosimilars for blockbuster drugs like Humira and Keytruda begin to enter the market, pharma giants are preparing for major potential losses. A swath of high-priced therapeutics is also facing the ends of their patents and exclusivity, but biosimilars are not interchangeable like generics, so companies may not take the massive hit they are anticipating.
India’s Department of Pharmaceuticals Holds Up NPPA Pricing Decision for Acetazolamide
Sun Pharma’s request to change the price cap set by India’s National Pharmaceutical Pricing Authority (NPPA) for acetazolamide 500 mg, a drug for glaucoma, has been rejected by the Department of Pharmaceuticals (DoP). The manufacturer had argued that the NPPA had based its pricing decision based on the 2021 price cap for the 250 mg capsule, not the increased price set in 2022.
Abarca CEO: Drug Pricing to Follow Model Set by Medicare Drug Negotiations Going Forward
With the impending Medicare drug pricing negotiations in the next few years, the future of drug pricing is uncertain in the US. According to Jason Borschow, CEO of the pharmacy benefit manager (PBM) Abarca Health, thinks that the pricing model will be the default for the pharma and biotech industries going forward.
US Govt Accountability Office Recommends FDA and HHS Improve IRB Inspection Oversight
The US Food and Drug Administration (FDA) and Department of Health and Human Services (HHS) received a rebuff from the Government Accountability Office (GAO) over their oversight over institutional review boards (IRBs) for clinical trials. IRBs, which help oversee ethics in research on the local level, are supposed to be overseen by the agencies, but in practice this rarely happens.
UK and US Reciprocal Drug Approvals Could Be on the Horizon
Marks & Clerk, an intellectual property firm based in London, says that reciprocal drug approvals between the UK and US may be on the horizon, potentially as early as 2024. The firm gleaned this information from a recent UK Medicines and Healtcare products Regulatory Agency guidance about international collaborations post-Brexit.
Moderna CEO Will Testify Before Senate Committee Headed by Sanders Over COVID Vaccine Price Hike
Stéphane Bancel, CEO of Moderna, will speak before a US Senate committee headed by Sen. Bernie Sanders (I-VT) over planned price hikes for the company’s COVID-19 vaccine. The shot, which the US federal government paid around $30 per dose for during the pandemic, will jump in price to $130 as it enters the market.
Labcorp Reveals Name for New CRO – Fortrea
Labcorp has announced that its upcoming clinical development spin-off will be named Fortrea. Fortrea will be independent and publicly traded, providing drug and health tech development and commercialization services to pharma and biotechs. Once spun off, Fortrea will begin with a workforce of 19,000 employees.
CMS to Try Out Reduced Payments for Drugs with Accelerated Approval
The US Centers for Medicare and Medicaid Services announced that it will test out a pilot program meant to push pharma companies to finish confirmatory studies on drugs that received accelerated approval. Patients and payer currently pay full price for these drugs, so CMS will try paying reduced price as a motivator to gather sufficient clinical evidence for a full approval.
District Court Case Could End Access to Abortion Pills in US
A District Court judge in Texas will decide the fate of access to abortion pills in the US. Judge Matthew Kacsmaryk, appointed to his office by Donald Trump, could decide to overrule the Food and Drug Administration’s long-standing approval of one of two drugs used for pharmaceutical abortions or limit access – even outside of the Lone Star State.
European Commission Expands Approval for AstraZeneca’s Heart Failure Drug
The European Commission has expanded its approval of AstraZeneca’s heart failure drug Forixga (dapaglifozin) for use in patients with mildly reduced or preserved left ventricular ejection fraction (LVEF), an important measure of heart function. The drug was previously indicated in use for heart failure patients with reduced LVEF and type 2 diabetes.
US State of the Union Address – Biden Will Veto Attempts to Repeal Inflation Reduction Act
During last night's (February 7th) State of the Union, US president Joe Biden emphasized the need to extend the $35 a month price cap on insulin to all Americans. In addition, he highlighted other provisions of the Inflation Reduction Act that will impact drug prices for many in the US, including the $2,000 out of pocket drug cost maximum for older adults on Medicare and upcoming drug pricing negotiations.
Biden Expected to Talk Drug Prices During State of the Union Address
During his State of the Union address tonight, February 7th, US President Joe Biden is expected to speak about high drug prices and his administration’s efforts to address them. A key talking point will likely be the $35 a month insulin price cap for patients on Medicare and efforts to make that price limit universal. In addition, he will likely discuss the provision of the Inflation Reduction Act that lets Medicare negotiate some drug prices.
Patient Advocates Petition 4 Governments to Open Path for Cystic Fibrosis Generics
Patient advocates around the world are asking the governments of South Africa, India, Ukraine, and Brazil to suspend Vertex Pharmaceuticals’ patents for TriKafta, a treatment for cystic fibrosis (CF). The treatment, which checks in at a whopping annual price of $326,000 in the US, is prohibitively expensive and out of reach of most patients in low- and middle-income nations.
Drug Price Inflation on the Rise
A new market projection by Vizient projects that inflation in drug prices is set to grow throughout the year, despite many drugs going generic or having biosimilars enter the market. The firm predicts that the drug price inflation rate will reach 3.78%, a jump from 2021’s increase of 3.2%.
Fierce Pharma’s 2023 Top 10 Upcoming Drug Launches
Fierce Pharma has just released their top 10 list of drug launches to watch in 2023. At the top of the list is lecanemab (Leqembi) Eisei and Biogen’s Alzheimer’s drug, which just entered the market this week under provisional approval. Next is SRP-9001, a gene therapy targeting Duchenne muscular dystrophy (DMD), a life-threatening progressive genetic condition.
Eisai Preps for Alzheimer’s Drug Launch
With the first patients receiving Leqembi last week, the new Alzheimer’s drug’s manufacturer Eisei is plotting out the drug’s rollout with last year’s Aduhelm controversy in mind. As such, the company, which received approval for the drug this January, is taking things slow and working carefully with payers to secure reimbursement ahead of a potential full approval in the near future.
FDA Grants Orphan Drug Status to GSK’s Systemic Sclerosis Therapeutic
The US Food and Drug Administration has granted Orphan Drug Designation (ODD) to GSK’s Benlysta (belimumab). The designation applies to the use of Benylsta in treating the interstitial lung disease (ILD) associated with systemic sclerosis (SSc), a rare autoimmune connective tissue disorder. The drug is currently approved for treating active lupus and lupus nephritis.
