Every week,
PharmaCompass compiles important developments in the world of pharmaceuticals
and brings a compilation to you in the form of Phispers. Of the hundreds of
stories we carried in 2023, here are the top 10 stories, including some trends
and updates.I. Pfizer buys Seagen for US$ 43 billion to
bolster its oncology portfolioIn March, Pfizer said it is acquiring cancer treatment specialist Seagen for US$ 43 billion. Seagen is a pioneer in antibody-drug conjugates
(ADCs), or drugs that work like “guided missiles” to destroy cancer cells while sparing healthy cells. Another important deal in the field of ADCs took place in December when AbbVie picked up ImmunoGen for US$ 10.1 billion, giving it access to Elahere (mirvetuximab soravtansine-gynx), an ADC approved for platinum-resistant ovarian
cancer. Elahere is expected to achieve blockbuster status by 2030. II.
Merck, BMS, trade bodies, sue US government over IRA negotiationsIn June, Merck filed a lawsuit against the US government seeking to block Medicare from negotiating lower
prescription drug prices under the Inflation Reduction Act (IRA). Days later,
the US Chamber of Commerce, one of the most influential trade groups in the US, filed a separate lawsuit, arguing
that the negotiations violated drugmakers’ constitutional rights and granted
excessive control over prices to the government. They were joined by Bristol Myers Squibb (BMS) and lobby group PhRMA. Drugmakers and
the Biden administration appeared to be at each other’s throats. In December, the White House identified 48 drugs whose prices spiked faster than inflation in Q4.
These drugs may be subject to rebates starting January 2024. Biden
Administration also announced it is setting a new “march-in” policy that allows the government to seize medicine patents held by drugmakers for therapies whose
development was taxpayer-funded, if it believes they are not “reasonably available and affordable.”III. US, UK approve Lilly’s Mounjaro for weight management; to be
sold as ZepboundIn November, drug
regulators in the US and the United Kingdom approved Eli Lilly's Mounjaro (tirzepatide) for weight management, to be sold under the brand name Zepbound. The drug will pose strong competition
to Novo Nordisk’s Wegovy in a market that's expected to reach US$ 100 billion by the end of
the decade.IV. Novo, Lilly plan capacity expansions for
weight loss drugsBoth Novo Nordisk and Eli Lilly announced expanding their manufacturing capacities in
order to capitalize on the burgeoning market for weight loss drugs. Novo is
investing over DKK 42 billion (US$ 6 billion) in Kalundborg (Denmark), US$ 2.3 billion to expand its site in Chartres (France) and over € 2 billion (US$ 2.18 billion) in Dublin (Ireland) to boost production of its blockbuster diabetes
and weight-loss drugs, including Ozempic and Wegovy (both semaglutide). Similarly, Eli Lilly had announced a US$ 2.5 billion manufacturing facility in Germany in November to address the demand for its new obesity and diabetes therapies.V. FDA finds violations at Global Pharma’s eye drops plant in India; issues Form
483In April, FDA
found several violations in manufacturing processes and sterilization methods
used by India-based Global Pharma for its EzriCare Artificial Tears Eye Drop, which has been linked to
68 cases of eye infection in the US, including eight cases of vision loss and three deaths.VI. ‘Intas India staff tore documents, threw acid to destroy evidence’, notes FDAIn January, FDA
issued a Form 483 with 11 observations to Intas Pharma’s
drug manufacturing facility in Ahmedabad (Gujarat, India). A team of three FDA
drug regulators conducted an inspection of the manufacturing facility from
November 22 to December 2, 2022. The 36-page report issued by the FDA has alleged that employees at the
facility had destroyed documents related to manufacturing practices by tearing
them into pieces and disposing them inside the quality control lab and scrap
areas. Acid was used to destroy evidence, notes FDA.VII. GSK overtakes Pfizer in bagging first FDA
approval for RSV vaccineIn May, FDA
approved GSK’s
respiratory syncytial virus (RSV) vaccine for people aged 60 and above. Arexvy is the first RSV vaccine to be approved in the US
for the common condition that can be fatal for the elderly. Later that month,
Pfizer’s RSV vaccine Abrysvo also got approved. In July, Sanofi-AstraZeneca’s
RSV antibody therapy, Beyfortus (nirsevimab-alip), received approval from the FDA. It is a long-acting treatment that can be given
once per season. The approval is specifically developed for newborns and
infants.VIII. UK authorizes gene therapy Casgevy for
blood disorders, US follows suit In November, Britain’s Medicines and Healthcare products Regulatory Agency was first off the block in authorizing CRISPR Therapeutics and Vertex Pharmaceuticals’ Casgevy, a therapy that seeks to cure two blood disorders — sickle-cell disease (SCD) and β-thalassemia. The therapy is based on gene editing technology that had won its scientists the Nobel Prize in Chemistry in 2020.Less than a month
later, FDA not only approved Casgevy (exagamglogene autotemcel) for SCD, but also approved bluebird bio’s
Lyfgenia (lovotibeglogene autotemcel) for the treatment of SCD in patients aged
12 and older who have a history of vaso-occlusive events (when tissues become
deprived of oxygen).IX. Leqembi becomes first med to bag full
approval to treat Alzheimer’sEisai and Biogen’s Alzheimer’s drug Leqembi (lecanemab) had won FDA’s accelerated approval in January. It treats patients who are in the earliest
stages of the neurodegenerative disease. In July, it became the first treatment to receive full FDA approval to treat the condition.X. Bayer’s experimental anticoagulant fails late-stage
trialOne of the
biggest disappointments from clinical trials came when a major late-stage trial for Bayer’s experimental anticoagulant asundexian had to be discontinued due to its inadequate effectiveness. Bayer had expectations in excess of € 5 billion (US$ 5.5 billion) from this drug.
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